A kit comprising vitamin d3, organic zinc, omega-3 fatty acids and n-acetylcysteine for the treatment of FLU and colds and their symptoms, and preventing the spread of infection

The combination of vitamin D3, organic zinc, omega-3 fatty acids, and N-acetylcysteine in a kit addresses the inadequacies of current treatments for flu and colds by strengthening the immune system and reducing the duration and spread of the diseases.

WO2025104344A1PCT designated stage expired Publication Date: 2025-05-22SULAIMAN JOHAN
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Patent Information

Application Number
PCT/EP2024/082733
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-17
Filing Date
2024-11-18
Publication Date
2025-05-22

AI Technical Summary

Technical Problem

Current treatments for flu and colds are inadequate in effectively stopping the diseases, alleviating symptoms, and preventing the spread of infection, leading to significant burden on the health system and society.

Method used

A kit comprising vitamin D3, organic zinc, omega-3 fatty acids, and N-acetylcysteine (NAC) is used to strengthen the immune system, alleviate symptoms, and prevent the spread of flu and colds.

Benefits of technology

The kit effectively shortens the duration of flu and colds, alleviates symptoms, and prevents the spread of infection, reducing the burden on the health system and improving quality of life.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a composition comprising vitamin D3, zinc, omega-3, and N-acetylcysteine (NAC), for use in the prevention of a disorder linked to the immune system, and symptoms of such disorder, wherein such disorder includes any one of a cold, a flu, an upper respiratory infection and a viral infection; preventing or alleviating an allergy; preventing of spread of infection; preventing a cold or a flu from developing into an asthma attack in an asthma patient. The composition is also used for alleviating the symptoms of a disorder linked to the immune system; and for use in shortening the duration of such disorder.
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Description

[0001] A KIT COMPRISING VITAMIN D3, ORGANIC ZINC, OMEGA-3 FATTY ACIDS AND N-ACETYLCYSTEINE FOR THE TREATMENT OF FLU AND COLDS AND THEIR SYMPTOMS, AND PREVENTING THE SPREAD OF INFECTION

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a composition comprising vitamin D3, zinc, omega-3 fatty acids, and N-acetylcysteine (NAC), for use in the prevention of a disorder linked to the immune system, and symptoms of such disorder, wherein in such disorder includes any one of a cold, a flu and upper respiratory infections; preventing of spread of infection; preventing a cold or a flu from developing into an asthma attack in an asthma patient. The composition is also used for alleviating the symptoms of a disorder linked to the immune system; and for use in shortening the duration of such disorder.

[0004] TECHNICAL BACKGROUND

[0005] Colds and flu are among the most widespread diseases in the world, and since these diseases are contagious and affects the upper respiratory system, they spread very quickly from the sick person to others, such as by the shaking of hands or through droplets released when a sick person coughs, sneeze or even exhale. These droplets may contain the virus and if they are inhaled, they may cause an infection. This spread is especially a risk in confined spaces at home, the cinema, public transport, etc., and is the main cause for colds and flu, estimated to account for no less than 75% of illness cases.

[0006] In Europe, every adult suffers from two to five cases per year of upper respiratory tract infections, while the infection rate in children is two to three times higher than in adults (Thomas and Bomar, Upper Respiratory Tract Infection, Treasure Island (FL), StatPearls Publishing, 2024 Jan-). The proportion also increases in the elderly, and some of them may be seriously ill. Most infections occur in the winter and fall. Colds last an average of 10 days, while some illnesses persist for weeks or more. For people suffering from chronic diseases, flu and colds can have a particularly serious effect because the immune system is already weakened by the underlying disease. According to the World Health Organization (Influenza (Seasonal), WHO Fact Sheet, 3 October 2023), respiratory diseases associated with seasonal influenza affect billions of people worldwide, including 3-5 million severe cases, and kill up to 650,000 people each year. These figures indicate the heavy burden of influenza and its great social and economic costs to the world.

[0007] Vaccines are generally advocated for routine use during each seasonal outbreak of influenza, based on the prevailing strain from the previous season; however, due to the unpredictable nature of influenza epidemics, the success of any vaccine cannot be certain, and several researchers have questioned the wisdom of widespread vaccination. Several antiviral drugs have been tested for use in infected patients experimentally, in animal models and in humans, but none have been satisfactorily proven. Newer synthetic compounds are the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza), but drug-resistant strains of avian and human influenza viruses are common. It is always recommended to avoid contact with people who are ill with the flu, and those that need to be in contact with a sick subject should take precautions such as wearing a mask and frequently washing their hands.

[0008] In general, when a patient is infected with a virus in the upper respiratory tract, inflammation develops in the nose and throat including the tonsils and pharynx, the mucous membrane of the nose and throat becomes irritated and then congested, causing difficulty in breathing and coughing, redness of the throat and pain, followed by copious mucus secretions to help get rid of pathogens. The throat becomes severely inflamed and painful due to inflammation of the mucous membrane and due to present bacteria. This is followed by coughing as a sure result of congestion in an attempt to get rid of virus and phlegm. The change in the voice and its hoarseness indicate the extent of this irritation in the throat. The infection can also include fatigue, headache, earache, fever, lung problems, muscle and joint pain, chills and body aches, decreased appetite. These are all part of the body's response to a viral infection and are among the common symptoms of such an infection that can last for several weeks. These symptoms may extend to an infection of the lower respiratory tract with other infections indirectly due to infection with the virus. In such cases, the affected, or some of them, need to take painkillers, antipyretics, decongestant sprays, anti-inflammatory drugs and cough medicines. It can also be accompanied by use of asthma medications, etc. Most of these medications do not treat the disease and have no significant role in reducing the duration of the disease, but rather try to relieve its symptoms, and these medications also have side effects. During this period of illness, the infected person is forced to isolate themselves perhaps and to miss work and stay at home and may need to be hospitalized.

[0009] Some studies conclude that an intake of vitamins, minerals and herbs for the treatment of some diseases, such as the flu or a common cold, can shorten the duration of the disease by a marginal percentage, but that such intake cannot relieve the symptoms (Hahn et al., BMJ. 2022, 376:e066452; Grant, et al., Nutrients 2020, 12(4), 988; Bychinin, et al., Sci Rep 2022, 12, 18604; Read, et al., Advances in Nutrition, 2019, 10(4), 696- 710; )..

[0010] There is thus a need for effectively stopping these diseases and getting rid of the symptoms, in order to stop their spread and reduce the burden on the health system and society at large.

[0011] SUMMARY OF THE INVENTION

[0012] The present invention relates to a kit comprising a combination of vitamin D3, organic zinc, omega-3 fatty acids, and N-acetylcysteine (NAC). The kit according to the present invention is useful for controlling the primary cause of diseases, such as flu and colds in all its forms, stomach flu, and viral infections; as well as for alleviating, allergies, eczema and autoimmune diseases, in mammals in general and humans in particular. It can also be used for stopping such diseases as soon as they appear, and preventing the onset of their symptoms, or at least prevent their development and alleviate the symptoms; and for replacing the need for antihistamine tablets and other drugs. The present invention relates to dosage regimes comprising the kit.

[0013] The kit according to the present invention comprises natural and nutritional supplements and can prevent the occurrence of coughs, runny noses, and body temperature increases, thereby eliminating the need of anti-inflammatory agents and painkillers. The kit and dosage regimes according to the invention contribute to a positive development for public health by controlling flu and colds, which can reduce the burden on the health system and increase the people's quality of life, thereby having the potential of making the world's population healthier.

[0014] The kit and the dosage regimes according to the present invention are defined in the appended claims.

[0015] DETAILED DESCRIPTION OF THE INVENTION

[0016] In a first aspect, the present invention relates to a kit comprising 800-60 000 IU vitamin D3, organic zinc in an amount corresponding to 7-250 mg elemental zinc, 300-6000 mg omega-3 fatty acids, and 100-5000 mg N-acetylcysteine (NAC), for use in the treatment, alleviation of the symptoms of, and prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu and upper respiratory infections, stomach ailment, and a viral infection; allergies, eczema and autoimmune diseases; spread of infection; and a cold or a flu from developing into an asthma attack in an asthma patient.

[0017] The present invention relies on strengthening the immune system with a composition of vitamins, minerals, fatty acids, and amino acids. Each component of the kit has a specific role in supporting and strengthening the immune system in general and affects the upper respiratory tract, thereby impacting colds and flu, and other viral infections, as well as reducing spread of infection. The kit may also be used as a dietary supplement.

[0018] The amount of 800-60 000 IU vitamin D3, corresponds to 20-1 500 pg vitamin D3 (Vitamin D - Fact Sheet for professionals, NIH Office of Dietary Supplements). Vitamin D3, also known as cholecalciferol, plays an effective role in general health, as it maintains bones and controls the body's overall balance. It also supports the immune system in various forms. It helps increase the production of antimicrobial peptides in cells, which helps fight infections. Vitamin D3 affects the activation of immune cells, such as natural killer cells, and regulates the immune system's response, which helps reduce unnecessary inflammation in the body, and helps alleviate autoimmune diseases. Vitamin D3 has been shown to stimulate cathelicidins and defensins, which can reduce virus replication speed and reduce concentrations of pro-inflammatory cytokines in the lungs, while increasing anti-inflammatory cytokines. A deficiency in vitamin D3 may increase the risk of respiratory infections. Some studies have found that outbreaks of influenza illness in general and Covid-19 in particular occurred in winter when the concentration of active vitamin D3 in the body is at a minimum, and they recommended that people at risk of infection with influenza and / or Covid-19 take 10 000 IU (corresponding to 250 pg) of vitamin D3 over a period of weeks to rapidly raise the concentration of vitamin D3 in the blood, then followed by 5 000 IU (corresponding to 125 pg) per day. This study also advised that they should take larger doses in case of infection with Covid-19. According to a study, high doses of vitamin D3 showed a significant increase in the production of NK, NKT and NLR immune system cells. That is, vitamin D3 deficiency leads to a weakened immune system and an increased risk of infection, and also decreases the ability to fight such infections if they occur.

[0019] The organic zinc used herein may be present in the form of zinc glycinate. Zinc has a variety of direct and indirect antiviral properties, which are achieved through different mechanisms. Taking zinc supplements has the potential to improve antiviral immunity, both innate and humoral, restore depleted immune cell function, or improve normal immune cell function, especially in immunocompromised or elderly patients. Zinc is effective against viruses primarily by preventing the virus from entering the cell, on the other hand it prevents virus replication by altering the proteolytic processing and RNA polymerase in a number of viruses, such as rhinovirus and influenza. Zinc acts to increase adaptive immune T cells and improve their function. It also increases their numbers in the periphery. The higher the percentage of zinc in the blood, the greater its role in improving the work of T cells and increasing their number. Zinc supplementation reduces the production of inflammatory cytokines and reduces markers of oxidative stress. Populations suffering from zinc deficiency are often at greater risk of viral infections. Thus, zinc deficiency leads to a weakened immune system and an increased risk of infection.

[0020] Omega-3 are essential fatty acids that have a major role in strengthening the immune system through their anti-inflammatory properties, as support for the immune system's B and T cells, and in the production of cytokines that are important for the immune system to function effectively. Omega-3 also plays a role in improving the immune system's ability to fight viral infections by increasing the production of phagocytes and macrophages, natural killers that fight cells infected with viruses and cancer cells. Omega-3 can be useful in the treatment of inflammatory and autoimmune diseases, arthritis and migraine, and that it reduces the need to use anti-inflammatory drugs.

[0021] N-acetylcysteine (NAC) is a compound that contains the amino acid cysteine, which is an important element in the production of antioxidants called glutathione in the body. Therefore, it has an important role in reducing oxidative stress and inflammation that occurs during a cold or flu infection. It also improves the immune system by producing certain immune cells and improving their function, such as immune cells, T cells, macrophages and neutrophils, and it also has an important role in reducing phlegm and cough. N-acetylcysteine can prevent the multiplication of seasonal influenza viruses and to prevent viruses from entering cells, including the SARS-CoV-2 virus. It is a mucolytic agent and an antidote for hepatotoxicity and a powerful antioxidant against free radicals in the body due to its role in increasing the production of glutathione. N-acetylcysteine, with its antioxidant properties, can play a helpful role in treating severe cases of Covid- 19 and in controlling its fatal complications, including lung damage, and cardiovascular damages, if used in high doses (especially intravenously).

[0022] The exact mechanism of the combination of the components in the kit according to the present invention is not yet known with a high degree of precision. However, it is assumed, without any intention to adhere to any theory, that this combination is an immensely powerful anti-inflammatory and antioxidant, so that zinc, for example, captures and destroys the primary virus colonies in the sinus cavity, thus interrupting colds. It also increases the production of immune cells. In all its forms, vitamin D3 regulates the response of the immune system, helps to cleanse the body of both bacteria and viruses, performs the task of autophagy of old and damaged cells, reduces inflammation and reduces oxidative stress in the body. Both omega-3 fatty acids and N- acetylcysteine (NAC), in turn support the immune system as described herein. Taking these supplements helps reduce oxidative stress and the inflammatory response and helps eliminate free radicals that increase as a natural result of the immune system's defense of the body in the event of this infection. This oxidative stress and inflammatory reaction can produce fever, headache, muscle pain, fatigue, cough, sneezing and runny nose, and this might explain why these manifestations disappear with the use of the kit according to the present invention.

[0023] In one embodiment, the kit comprises 20000-40 000 IU vitamin D3 (corresponding to 500-1000 pg), organic zinc in an amount corresponding to 50-100 mg elemental zinc, 1000-3000 mg omega-3 fatty acids, and 800-2400 mg N-acetylcysteine (NAC). In a more specific embodiment, the kit comprises 40 000 IU vitamin D3 (corresponding to 1 000 pg), organic zinc in an amount corresponding to 100 mg elemental zinc, 3000 mg omega- 3 fatty acids, and 2400 mg N-acetylcysteine (NAC). Studies have differed on the percentage, but on average 75% of people are deficient in one or more minerals or vitamins, and this may explain why people around the world were affected by the coronavirus and its complications. The components of the kit according to the present invention are natural substances that the body needs on a daily basis, unlike traditional treatment methods. This minimizes the risk for side effects. A large percentage of people today do not get enough nutrients, including vitamins and minerals.

[0024] Using the kit for treatment enables individuals to meet and socialize with other healthy people without infecting them.

[0025] In the case of mild diseases or weak viral or bacterial infections, especially when the affected subject has a strong immune system or has been exposed to the infection for a relatively short period, the use of vitamin D3 and zinc alone may be sufficient to treat or prevent an infectious disease in the upper respiratory tract. Especially when these ingredients are used at the first onset of the disease and the subject has obtained sufficient sleep. The optimal effect of the mixture is based on using the ingredients together within the recommended doses.

[0026] In one embodiment the kit according to the present invention further comprises organic copper in an amount of 0.25-6 mg elemental copper; 50-600 pg vitamin K2; and organic magnesium in an amount of 25-1000 mg elemental magnesium. Preferably, the kit comprises organic copper in an amount of 0.5-3 mg elemental copper; 100-300 pg vitamin K2; and organic magnesium in an amount of 100-300 mg elemental magnesium.

[0027] While vitamin D3 causes the level of calcium in the blood to increase, vitamin K2 contributes to increase the absorption of vitamin D3 and for transferring excess calcium from the blood to the bones. Thereby accumulation of calcium in blood vessels and other organs is prevented. The organic copper may be present in the form of copper glycinate. Copper balances the amount of zinc as copper and zinc interact with each other in many ways. The optimal ratio of copper to zinc varies depending on several factors, including age, sex, diet, and health. Preferably, the amount of zinc is higher than the amount of copper. In one embodiment the ratio of copper to zinc is around 1:8 or 1:10. Copper also plays a key role in the formation of white blood cells and improves the immune response.

[0028] In the kit according to the present invention, the organic magnesium may be present in the form of magnesium glycinate. Magnesium plays an important role in the activation of enzymes involved in the conversion of vitamin D3 to its active form, also known as calcitriol, in the body. It also improves its absorption and helps regulate immune activity and improve the body's response to inflammation.

[0029] A kit combining vitamin D3, organic zinc, N-acetylcysteine, omega-3 fatty acids, vitamin K2, organic copper and organic magnesium has been proven to be effective for use in the treatment, alleviation of the symptoms of, and prevention of diseases linked to the immune system in mammals, as well as spread of infection, and preventing a cold or a flu from developing into an asthma attack in an asthma patient.

[0030] Almost every individual feels certain symptoms predicting that the symptoms of a cold are about to set in. These can manifest in many forms, depending on the individual, but it usually starts as an itchy feeling inside the nose and is sometimes accompanied by sneezing. The combination of vitamins and minerals and fatty acids and amino acids in the kit according to the present invention strengthens the immune system in mammals, including humans. The ingredients of the treatment are natural substances that the body needs daily unlike traditional treatment methods. No side effects have been recorded when using the kit. Use of the kit enables meeting and socializing with other healthy people without having to worry about the others getting infected. A kit with the specific combination according to the present invention strengthens the immune system in all its parts to be able to resist the disease and eliminate it, quickly and with high efficiency without any or minimal cold symptoms. In other words, this means a faster recovery, reduced inflammation, improved immune function and lower mortality.

[0031] Disease symptoms that may be alleviated by using then kit according to the present invention include fever, i.e. an elevated body temperature. Use of the kit not only prevents the onset of fever as a symptom of illness, but it has also the ability to lower the temperature in individuals who have already developed a fever, thereby bringing the body temperature closer to normal within a few hours of consumption. This has been observed in many people who have used the claimed kit, both adults and children. This effect may be attributed to its ability to support the immune system, regulate the immune response, and reduce inflammation, which may help alleviate symptoms associated with infection.

[0032] In one embodiment, the kit according to the present invention is for daily use, for example as a dietary supplement, together with a fatty diet to increase the absorption of the components of the kit.

[0033] In one embodiment, the components of the kit are for oral administration, for intramuscular injection, or for intravenous injection. Intravenous injections can be particularly useful in severe illness, especially for people with chronic diseases.

[0034] In one embodiment the components of the kit are gathered in a pill, tablet or capsule. This administration form enables the person to keep the kit permanently close to them for the purpose of being used immediately when the symptoms of a cold or flu or the other diseases mentioned above is felt.

[0035] In one embodiment, the kit comprises a dry form and a liquid form, wherein the dry form comprises one or more pills; tablets, including sublingual tablets; or capsules; and wherein the liquid form comprises capsules. The dry and liquid forms can be combined in capsules with two or multiple layers or compartments. In some embodiments, vitamin D3, zinc, N-acetylcysteine, copper, vitamin K2 and magnesium are dry ingredients. In some embodiments, omega-3 fatty acids are in a liquid form. In one embodiment, vitamin D3, zinc, N-acetylcysteine, copper, vitamin K2 and magnesium are in the form of a tablet. In one embodiment, vitamin D3, zinc, N-acetylcysteine, copper, vitamin K2 and magnesium are combined with omega-3 fatty acids in vegetable- or gelatin capsules. In one embodiment, the kit is in a liquid form.

[0036] In one embodiment, the kit according to the present invention is a paediatric formulation. In one embodiment, the amount of each component in the paediatric formulation is % to1of the amounts defined in the kit according to the present invention, such as 200-30 000 IU vitamin D3, organic zinc in an amount corresponding to 2-125 mg elemental zinc, 75-3000 mg omega-3 fatty acids, and 25-2500 mg N- acetylcysteine (NAC). In a further embodiment, the paediatric formulation comprises 2500-10 000 IU vitamin D3; 8-25 mg elemental zinc; 200-2500 mg omega-3 fatty acids; 200-1200 mg N-acetylcysteine (NAC), 0.1-1.5 mg elemental copper; 25-150 pg vitamin K2; and 20-150 mg elemental magnesium. More specifically, the paediatric formulation may comprise 2500-10000 IU vitamin D3; 12-25 mg elemental zinc; 250-600 mg omega- 3 fatty acids; 250-500 mg N-acetylcysteine (NAC); 0.25-1 mg elemental copper; 25-100 pg vitamin K2; and 25-60 mg elemental magnesium.

[0037] In a second aspect, the present invention relates to a dosage regime comprising three individual doses a day, wherein each dose comprises a kit according to the first aspect of the present invention, and wherein the first daily dose contains the highest amount of vitamin D3 and zinc of the three doses.

[0038] The kit can be administrated in specific doses and frequencies when symptoms of a cold or flu, or a stomach ailment, allergies, eczema, and autoimmune diseases are experienced. Administrating a dose at the beginning of the disease, preferably with the first 30 minutes up to 2 hours of the onset of the symptoms, is effective in preventing and stopping upper respiratory infections, including colds and flu, and viral infections; preventing symptoms of such diseases from occurring; preventing spread of infection; as well as preventing colds and flu and viral infections from developing into asthma attacks in asthma patients. The kit can also be used for preventing the development such diseases once they have started and for alleviating the symptoms of such diseases, as well as shorten the duration of such diseases. The symptoms of the initial cold or flu infection do not develop further, but rather end immediately, such as within 2 hours of administration, or from 45 minutes to 2 hours of administration. Early administration prevents the virus from multiplying and spreading immediately, but even if the first dose is not taken until the disease has taken hold, the symptoms can be alleviated and shorten the duration of the disease to a maximum of 3 days.

[0039] The present invention aims to maintain a sustainable immune system within a normal state of health, instead of treating disease symptoms according to current traditional treatments. The ingredients contained in the composition according to the present invention support the immune system so that it can defeat the infection with the least possible effort. Thus, the kit for use according to the present invention contributes to employees no longer having to be absent from work or students absent from their schools due to colds. Also, a significant reduction in the number of deaths from seasonal flu and other viral diseases is possible to reach.

[0040] The effectiveness of a dose as presented herein used for treatment of an illness is between 6-8 hours. Thus, the dosage regime according to the present invention preferably consists of 3-4 doses per day. More preferably, the dosage regime preferably consists of 3 doses per day and an interval of 8 hours between each dose.

[0041] The present inventor has found that the effectiveness of nutritional supplements does not last longer than 6-8 hours. The specific doses and frequencies are critical to managing symptoms at the first sign of illness. Nutritional supplements in common art are in general given in high doses but only once a day, but this is not effective. If a dose is not administered at the initial appearance of symptoms and before the disease spreads, and if its effective period of 6-8 hours is not fully utilized, the virus can resume its activity during the remaining time of the day, which is about 16 hours. This can worsen the patient's condition and make the next day's dosage less effective.

[0042] The kit according to the present invention not only stops the virus, but also works as a painkiller, and enables the infected person to return to being a healthy person and to perform his normal daily activities already shortly after taking the first dose. When the time to take the next dose approaches, the effect of the first dose has started to wane, and here the infected person may feel some dryness and / or pain in the throat. This may function as a reminder to take the next dose. Shortly after taking the next dose the dryness and pain disappear.

[0043] In one embodiment, the dosage regime comprises three individual doses a day, wherein each dose comprises a kit according to the first aspect of the present invention, as presented in Table 1 below:

[0044] Table 1 for use in the treatment, alleviation of the symptoms of, and prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu, an upper respiratory infection, stomach ailment, and a viral infection, allergies, eczema and autoimmune diseases, spread of infection, and a cold or a flu from developing into an asthma attack in an asthma patient.

[0045] This dosage regime is preferred for a severe disease state, for elderly people or people with chronic diseases.

[0046] In a specific embodiment, the dosage regime comprises three individual doses a day, wherein each dose comprises a kit according to the first aspect of the present invention, as presented in Table 2 below:

[0047] Table 2 for use in the treatment, alleviation of the symptoms of, and prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu, an upper respiratory infection, stomach ailment, and a viral infection, allergies, eczema and autoimmune diseases, spread of infection, and a cold or a flu from developing into an asthma attack in an asthma patient.

[0048] Administration of the first dose at the first feelings of the disease, such as within from 45 minutes to 2 hours, provides for a great possibility that the disease will be completely eliminated within 24 hours. In any of the above embodiments of the dosage regime, the time interval between the intake of each dose is 6-8 hours. In one embodiment, the dosage regime is intended for daily use by a human during cold and flu or viral infections during a period of from 3-7 days. As have been evidenced by the enclosed examples, there were no symptoms of coughing, sneezing, fever, fatigue or muscle pain for those who completely adhered to the treatment.

[0049] The dosage regime for a child may also comprise comprises three individual doses a day of a paediatric formulation. In one embodiment, the amount of each component in each of the three daily doses of a paediatric formulation is % to1of the amounts defined for each of the doses in table 2.

[0050] A further aspect of the present invention relates to a dosage regime comprising one dose a day for use in the prevention of an upper respiratory infection, such as a cold or a flu, a viral infection, or allergies, wherein the dose comprises the ingredients and amounts according to table 3.

[0051] Table 3

[0052] Preferably the daily dose is taken in the morning, for example just before leaving home for work, allowing the effect of the dose to last during the working day. In a specific embodiment the daily dose comprises 20 000 IU vitamin D3, 50 mg elemental zinc, 1000 mg omega-3 fatty acids, 800 mg N-acetylcysteine (NAC), 1 mg elemental copper, 100 pg vitamin K2, and 100 mg elemental magnesium.

[0053] Using the kit and dosage regimes according to the present invention not only protects against viral infections affecting the upper respiratory tract, but also prevents the infections from spreading to the lower respiratory tract and lungs and resulting in bronchiolitis or pneumonia. These symptoms may not be a direct result of virus replication, which in many cases is minimal in differentiated airway tissues, but rather an indirect consequence of virus-induced inflammatory responses.

[0054] Even if symptoms of a cold and flu disappear completely, or almost completely, the disease can remain in the body for some time. Administration of the first, second and third dose with an interval of eight hours between each dose, at least for three days, is thus recommended to avoid the disease to reappear.

[0055] A further aspect of the present invention relates to the treatment, alleviation of the symptoms of, and prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu and upper respiratory infections, stomach ailment, and a viral infection; allergies, eczema and autoimmune diseases, and viral infections; spread of infection, and a cold or a flu developing into an asthma attack in an asthma patient; by administration of a kit according to the present invention, said kit comprising 800- 60000 IU vitamin D3, organic zinc in an amount corresponding to 7-250 mg elemental zinc, 300-6000 mg omega-3 fatty acids, and 100-5000 mg N-acetylcysteine (NAC).

[0056] In another aspect, the present invention relates to a pill container for storing the first dose of the kit. The pill container makes it easier to always have the first dose at hand. Preferably, the pill container is equipped with a device suitable for attaching the pill containerto a key ring. The pill container may have the form of a tube with a size suitable of accommodating a kit with a first dose according to the invention. The tube is preferably equipped with a removable end cap.

[0057] All aspects and embodiments disclosed herein can be combined with any other aspect and / or embodiment disclosed herein.

[0058] The invention is illustrated by the following examples.

[0059] EXAMPLES Materials

[0060] A kit comprising the doses presented in table 4 were used throughout the examples presented below.

[0061] Table 4 Example 1

[0062] The composition was administrated to 40 humans for more than two years and the results are as follows.

[0063] For most of the subjects the length of the illness lasted no more than a day, and none of them had to take the composition for more than three days. No side effects were recorded.

[0064] Example 2

[0065] Test person: 62-year-old man.

[0066] Height: 186 cm and weight: 85 kg

[0067] The test person felt he was going to catch a cold. The first dose was taken, and the test person felt the cold disappear instantly. A second dose was taken in the evening. The test person felt that the cold had completely disappeared.

[0068] Example 3

[0069] Test person: 49-year-old man:

[0070] Height: 181 cm and weight: 80 kg

[0071] First illness: The test person took the first dose at the onset of a cold, i.e. at the time when you realize a cold is coming. The symptoms disappeared after about an hour, and his day went on as usual without any sick symptoms. In the evening the test person felt a slight dryness in his throat. The second dose was taken, and the test person went to bed. The next day the test person did no longer feel sick and did not take any further doses of the composition. Second illness: The test person took the large, recommended dose at the onset of the cold. The symptoms disappeared after about an hour. There were no symptoms of illness during the day. About 12 hours after taking the first dose the test person made a physical exertion and felt pain and dryness in the throat. About 14 hours after the first dose, a second dose was taken, and the test person went to bed. The next morning the test person felt that his body was healthy, but there was a hoarseness in his voice and a slight feeling of sinus congestion. This impression of a cold may be due to the second dose being taken long after the first dose, and to the exhaustion from the physical exertion during treatment.

[0072] The test person continued taking the recommended doses for two consecutive days without developing any cold symptoms, and then stopped this treatment.

[0073] Third illness: Just as in the first case above. The treatment was 100% successful. Fourth illness: Just as in the first case above. The treatment was 100% successful.

[0074] Example 4

[0075] Test person: 39-year-old man.

[0076] Height: 182 cm and weight: 88 kg

[0077] The test person felt like he was going to catch a cold with symptoms such as a sore throat and the onset of sniffling. The first dose was taken about two hours after the first symptoms. The symptoms of the cold disappear instantly. In the evening, after an 8- hour workday, the symptoms of a sore throat and general physical fatigue returned. A second dose was taken, and the test person went to bed. In the morning there were no signs of illness or any symptoms. The test person took the third and final dose and felt that the cold has completely disappeared.

[0078] Example 5

[0079] Test Person: 37-year-old woman:

[0080] Height: 170 cm and weight: 63 kg

[0081] The test person felt she was starting to catch a cold and took the first dose. The symptoms of a cold disappeared after about an hour. During the day the test person did not feel any symptoms of illness. In the evening a second dose was taken. The following day the disease had completely disappeared. This test person had suffered from asthma for many years and always carried asthma medication with her. After each cold, asthma attacks usually occurred. While the cold generally subsided after about a week, the asthma symptoms such as cough, shortness of breath, and wheezing continued to recur and were debilitating, sometimes for several weeks or even months. The test person started to use the composition according to the present invention at the onset of a cold and continued taking a dose of the composition almost daily for two years to support her immune system. During this period, the test person has not experienced any asthma attacks.

[0082] Example 6

[0083] Test person: 24-year-old man.

[0084] Height: 194 cm and weight: 90 kg

[0085] The test person took the first, second and third dose on the first day. He describes that he felt that the cold had completely disappeared after the first dose. He took no further doses after the third dose.

[0086] Example 7

[0087] Test person: 17-year-old boy.

[0088] Height: 181 cm and weight: 75 kg

[0089] First illness: The test person felt the symptoms of a cold, which consisted of a sore throat and general weakness. The first dose was taken about 6 hours after the onset of the infection. The second and third doses were not taken at the recommended times. Instead, the second dose was taken 8 + 6 hours after the first dose, and the third dose was taken 8 + 2 hours after the second dose. The test person still felt nasal congestion after the third dose. Then he continued to follow all the recommended doses every eight hours. Under the supervision of his parents, he woke up the next day experiencing relief, and that his nostrils had opened again, making it easier for him to breathe normally. After waking up on the subsequent day, there was no effect of the cold on him. The cold has completely disappeared.

[0090] The cold period lasted for about 3 days.

[0091] Second illness: The test person trained hard and got sweaty before going home in freezing cold wearing only very light clothes. At home, the test person felt feverish with a sore throat and a runny nose. The test person took the first recommended dose and went to bed. The following day the test person felt no symptoms of the disease and did not take any further doses.

[0092] This test person had suffered from asthma for many years and after a cold, asthma attacks usually occurred. While the cold generally subsided after about a week, the asthma symptoms such as cough, shortness of breath, and wheezing continued to recur and were debilitating, sometimes for several weeks or even months. The test person started to use the composition according to the present invention at the onset of a cold and continued to take a dose of the composition almost daily for two years to support his immune system. During this period, the test person has not experienced any asthma attacks.

[0093] Example 8

[0094] Test person: 15-year-old boy.

[0095] Height: 183 cm and weight: 70 kg

[0096] First and second illness: The test person felt he was starting to catch a cold and took the first dose. The feeling of an illness went away. The test person did not take any further doses.

[0097] Third illness: The test person took the first dose when he felt that he was starting to catch a cold. The remaining doses were not taken at the recommended times. The second dose was taken about 10 hours after the first dose, and the third dose was taken about 24 hours after the second dose. Symptoms of a cold, such as sore throat, cough and runny nose, appeared. The test person then took the recommended doses every eight hours and the runny nose and sore throat disappeared, but his hoarseness remained and nasal congestion. The cold period lasted for about 3 days. Example 9

[0098] Test person: 14-year-old boy.

[0099] Height: 170 cm and weight: 67 kg

[0100] The test person felt he was starting to catch a cold and took the first dose. The symptoms disappeared after about an hour, and his day went on as usual without any ill symptoms. No further doses were taken.

[0101] Example 10

[0102] Test person: 50-year-old man:

[0103] Height: 181 cm and weight: 80 kg

[0104] The test person had breathing difficulties for a long time due to pollen allergy and therefore used to take a whole or half tablet of antihistamine almost daily. When this person started taking a daily dose in the morning of the composition corresponding to the second dose in Table 4, the test person felt that he no longer needed the antihistamine.

[0105] Example 11

[0106] Test persons: Men and women between the ages of 15 and 50.

[0107] The test persons had difficulty getting a good night's sleep due to breathing difficulties caused by allergies. They experienced that they fell asleep more easily after regularly taking a daily dose of the of the composition corresponding to the second dose given in Table 4.

[0108] Example 12

[0109] Test person: 3-year-old girl.

[0110] The test person was given half an adult dose, i.e. half of the second dose given in Table 4, twice a day each time cold symptoms appeared, and the cold then disappeared quickly. Example 13

[0111] Test person: 3-year-old girl.

[0112] The test person contracted stomach disease in pre-school where other children were infected with this disease. The test person had symptoms such as a fever, 38 °C, fatigue and crying. She was given half of the second dose of the composition given in Table 4, about half an hour after the onset of symptoms. After about an hour, her temperature had dropped to 36 °C, and the girl returned to an almost normal lifestyle. In the evening, the fatigue returned, and she was given another half dose. After two hours she was active and showed no signs of the disease. The disease has thus disappeared and did not return the next day.

[0113] Example 14

[0114] Test person: 3-year-old girl.

[0115] The test person had developed eczema all over her body at the age of 1-2 years. The eczema was treated by daily application of prescription cortisone creams. When treatment with the cortisone creams stopped, the eczema returned as large red spots all over the body. The test person received half of the second dose of the composition as described in table 4, twice a day for two consecutive days. Then about 80% of the eczema had disappeared by from her body after previously having covered her entire body.

[0116] The test person is given half a dose of the composition now and then and the eczema has almost completely disappeared.

Claims

CLAIMS1. A kit comprising 800-60000 IU vitamin D3, organic zinc in an amount corresponding to 7-250 mg elemental zinc, 300-6000 mg omega-3 fatty acids, and 100-5000 mg N-acetylcysteine (NAC), for use in the treatment, alleviation of the symptoms of, and prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu and upper respiratory infections, stomach ailment, and a viral infection, allergies, eczema and autoimmune diseases, spread of infection, and a cold or a flu from developing into an asthma attack in an asthma patient.

2. The kit according to claim 1, wherein the kit comprises 20000 - 40000 IU vitamin D3, organic zinc in an amount corresponding to 50-100 mg elemental zinc, 1000- 3000 mg omega-3 fatty acids, and 800-2400 mg N-acetylcysteine (NAC).

3. The kit according to claim 1, wherein the kit comprises 40 000 IU vitamin D3, organic zinc in an amount corresponding to 100 mg elemental zinc, 3000 mg omega-3 fatty acids, and 2400 mg N-acetylcysteine (NAC).

4. The kit according to claim 1 or 2, further comprising 50-600 pg vitamin K2; organic copper in an amount of 0.5-6 mg elemental copper; and organic magnesium in an amount of 25-1000 mg elemental magnesium.

5. The kit according to claim 3, wherein the kit comprises 100-300 pg vitamin K2; organic copper in an amount of 1-3 mg elemental copper; and organic magnesium in an amount of 100-300 mg elemental magnesium.

6. The kit according to any one of claims 1-5 for daily use together with a fatty diet to increase the absorption of the components of the kit.

7. The kit according to any one of claims 1-6, wherein the components of the kit are for oral administration, for intramuscular injection, or for intravenous injection.

8. The kit according to any one of claim 7, wherein the kit is in a dry and in a liquid form, wherein the dry form comprises one or more pills; tablets, including sublingual tablets; gummy tablets for children; or capsules; and wherein the liquid form comprises capsules.

9. The kit according to claim 7 or 8, wherein vitamin D3, zinc, N-acetylcysteine, copper, vitamin K2 and magnesium are in the form of a tablet.

10. The kit according to claim 7, wherein vitamin D3, zinc, N-acetylcysteine, copper, vitamin K2 and magnesium are combined with omega-3 in capsules.

11. The kit according to any one of claims 7, which is in a liquid form.

12. The kit according to any one of claims 1-11, which is a paediatric formulation.

13. The kit according to claim 12, wherein the amount of each component is % to1of the amounts defined in claim 1.

14. A dosage regime comprising three individual doses a day, wherein each dose comprises a kit according to any one of claims 1-2 and 4-5, and wherein the first daily dose contains the highest amount of vitamin D3 and zinc of the three doses.

15. A dosage regime comprising three individual doses a day, wherein each dose comprises a kit according to claim 1-2 and 4-13, as presented in the table below:for use in the treatment, alleviation of the symptoms of, or prevention of any one of a disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu, an upper respiratory infection, stomach ailment, and a viral infection, allergies, eczema and autoimmune diseases, spread of infection, and a cold or a flu from developing into an asthma attack in an asthma patient.

16. A dosage regime comprising three individual doses a day, wherein each dose comprises a kit according to any one of claims 1-13, as presented in the table below:for use in the treatment, alleviation of the symptoms of, or prevention of any one ofa disease linked to the immune system in mammals, and symptoms of such disease, wherein the disease includes any one of a cold, a flu and upper respiratory infections, stomach ailment, and a viral infection, allergies, eczema and autoimmune diseases, spread of infection, and a cold or a flu from developing into an asthma attack in an asthma patient.

17. The dosage regime according to any one of claims 14 to 16, wherein the time interval between the intake of each dose is 6-8 hours.

18. The dosage regime according to any one of claims 14 to 16, wherein when used in the treatment of the disease, or for alleviation of the symptoms thereof, the symptoms of the disease disappear within 2 hours of administration.

19. The dosage regime according to any one of claims 14 to 16 for daily use by a human during cold and flu, or a viral infection, during a period of from 3-7 days.

20. A dosage regime comprising one dose a day for preventing an upper respiratory infection, such as a cold or a flu, a viral infection, or an allergy, wherein the dose comprises:

Citation Information

Patent Citations

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