Supplement for reducing hair shedding, hair loss, increasing hair growth, reducing hair thinning, and improving mental health associated with hair thinning

Abstract

This invention relates to a split dose dietary supplement that contains key vitamins and minerals to increase hair thickness, increase hair growth, reduce hair thinning, reduce hair loss, and / or reduce hair shedding.

Description

[0001] SUPPLEMENT FOR REDUCING HAIR SHEDDING, HAIR LOSS, INCREASING HAIR GROWTH, REDUCING HAIR THINNING, AND IMPROVING MENTAL HEALTH ASSOCIATED WITH HAIR THINNING

[0002] FIELD OF INVENTION

[0003] This invention relates to a split dose dietary supplement that contains key vitamins and minerals to increase hair thickness, increase hair growth, reduce hair thinning, reduce hair loss, and / or reduce hair shedding.

[0004] BACKGROUND

[0005] Adequate levels of key vitamins and minerals are needed to support hair maintenance and health.

[0006] Many vitamin supplements aimed at increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding can be ineffective or only poorly effective in some patients.

[0007] STATEMENT OF THE INVENTION

[0008] In a first aspect of the invention is provided a kit for increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding; or for treating poor mental health associated with hair thinning, hair loss and / or hair shedding; the kit comprising two dosage forms: a) a first dosage form comprising iron, vitamin C, folic acid, vitamin B12 and vitamin D; and b) a second dosage form comprising selenium and zinc.

[0009] For the absence of doubt, the first dosage form and the second dosage form are different, i.e. they do not have the same composition.

[0010] In a second aspect of the invention is provided a use of the kit of the first aspect of the invention for increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss, and / or reducing hair shedding; or for treating poor mental health associated with hair thinning, hair loss and / or hair shedding.

[0011] In a third aspect of the invention is provided a cosmetic method of increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding in a subject, the method comprising: • administering a first dosage form each morning for a length of time T1 , said first dosage form comprising: iron, vitamin C, folic acid, vitamin B12 and vitamin D; and

[0012] • administering a second dosage form each evening for a length of time T 1 , said second dosage form comprising: selenium and zinc.

[0013] In a fourth aspect of the invention is provided a method of treating a condition selected from hair thinning, hair loss, hair shedding and / or poor mental health associated with hair thinning, hair loss and / or hair shedding in a patient in need thereof, the method comprising:

[0014] • administering a first dosage form each morning for a length of time T1 , said first dosage form comprising: iron, vitamin C, folic acid, vitamin B12 and vitamin D; and

[0015] • administering a second dosage form each evening for a length of time T 1 , said second dosage form comprising: selenium and zinc.

[0016] The inventor has determined that the key hair vitamins and minerals are iron, vitamin C, folic acid, vitamin B12, vitamin D, selenium and zinc. Often current hair multivitamins do not actually achieve adequate blood plasma levels of the key hair vitamins and minerals in all patients.

[0017] The inventor has found that splitting these key hair vitamins and minerals into morning and evening doses, enables adequate blood plasma levels of these vitamins and minerals to support hair maintenance and growth. The inventor has found that after 3 months on the dosage regime of the invention, for each subject:

[0018] • Optimal blood serum levels of key hair vitamins and minerals are reached, including iron, zinc, vitamin B12, folic acid, vitamin D, selenium and vitamin C.

[0019] • Subjects noticed a reduction in hair shedding.

[0020] • Subjects noticed an increase in hair growth.

[0021] • Subjects noticed thickening in hair.

[0022] • Subjects reported an improved quality of life.

[0023] Dosage Forms

[0024] The first dosage form may not comprise biotin. The second dosage form may not comprise biotin. It may be that neither the first dosage form nor the second dosage form comprise biotin. The first dosage form may be suitable for oral administration. The second dosage form may be suitable for oral administration. It may be that both the first dosage form and the second dosage form are suitable for oral administration.

[0025] The first dosage form may be a tablet. The second dosage form may be a tablet. It may be that both the first dosage form and the second dosage form are tablets.

[0026] The iron in the first dosage form may be provided by a compound selected from ferrous sulfate, ferrous gluconate, ferrous fumarate, ferrous bisglycinate, ferric citrate, ferric sulfate, or a mixture thereof. The first dosage form may comprise ferrous fumarate. The iron in the first dosage form may be provided by ferrous fumarate.

[0027] The first dosage form may comprise from 10 to 50 mg iron. The first dosage form may comprise from 12 to 30 mg iron. The first dosage form may comprise from 15 to 25 mg iron. The first dosage form may comprise around 20 mg iron. The quantities of iron in this paragraph refer to the mass of iron atoms in the dosage form. As an example, where the iron is ferrous fumarate, 20 mg of iron is provided by 65.4 mg of ferrous fumarate

[0028] The first dosage form may comprise from 100 to 500 mg vitamin C. The first dosage form may comprise from 150 to 300 mg vitamin C. The first dosage form may comprise from 150 to 250 mg vitamin C. The first dosage form may comprise from 175 to 275 mg vitamin C. The first dosage form may comprise around 200 mg vitamin C. The first dosage form may comprise around 250 mg vitamin C.

[0029] The vitamin B12 may be methylcobalamin. The first dosage form may comprise from 10 to 50 pg vitamin B12. The first dosage form may comprise from 15 to 35 pg vitamin B12. The first dosage form may comprise from 20 to 30 pg vitamin B12. The first dosage form may comprise around 25 pg vitamin B12.

[0030] The first dosage form may comprise from 200 to 1000 pg folic acid. The first dosage form may comprise from 350 to 650 pg folic acid. The first dosage form may comprise from 450 to 550 pg folic acid. The first dosage form may comprise around 500 pg folic acid.

[0031] The vitamin D may be selected from vitamin D, vitamin D2 and vitamin D3. The vitamin D may be vitamin D3.

[0032] The first dosage form may comprise from 1000 to 2000 IU vitamin D (e.g. vitamin D3, also known as cholecalciferol). The first dosage form may comprise from 1250 to 1750 IU vitamin D (e.g. vitamin D3). The first dosage form may comprise from 1400 to 1600 IL! vitamin D (e.g. vitamin D3). The first dosage form may comprise about 1500 IU vitamin D (e.g. vitamin D3).

[0033] The first dosage form may comprise from 10 to 50 mg iron, from 100 to 500 mg vitamin C, 10 to 50 pg vitamin B12, 200 to 1000 pg folic acid and from 1000 to 2000 IU vitamin D. The first dosage form may comprise from 12 to 30 mg iron, from 150 to 300 mg vitamin C, from 15 to 35 pg vitamin B12, from 350 to 650 pg folic acid from 1250 to 1750 IU vitamin D. The first dosage form may comprise from 15 to 25 mg iron, from 150 to 250 mg vitamin C, 20 to 30 pg vitamin B12, from 450 to 550 pg folic acid and from 1400 to 1600 IU vitamin D.

[0034] The first dosage form is typically for taking in the morning.

[0035] Typically, the first dosage form does not comprise selenium. Typically, the first dosage form does not comprise zinc.

[0036] The zinc in the second dosage form may be provided by a compound selected from zinc oxide, zinc piconolinate, zinc citrate, zinc sulfate, zinc acetate, zinc gluconate or a mixture thereof. The second dosage form may comprise zinc gluconate. The zinc in the second dosage form may be provided by zinc gluconate.

[0037] The second dosage form may comprise from 10 to 50 mg zinc. The second dosage form may comprise from 15 to 35 mg zinc. The second dosage form may comprise from 20 to 30 mg zinc. The second dosage form may comprise around 25 mg zinc. The quantities of zinc in this paragraph refer to the mass of zinc atoms in the dosage form. As an example, where the zinc is zinc gluconate, 25 mg of zinc is provided by 203.3 mg of zinc gluconate.

[0038] The selenium in the second dosage form may be provided by a compound selected from selenomethionine, sodium selenite, sodium selenate, or a mixture thereof. The second dosage form may comprise sodium selenite. The second dosage form may comprise anhydrous sodium selenite. The selenium in the second dosage form may be provided by sodium selenite. The selenium in the second dosage form may be provided by anhydrous sodium selenite.

[0039] The second dosage form may comprise from 10 to 500 pg selenium. The second dosage form may comprise from 50 to 200 pg selenium. The second dosage form may comprise from 85 to 135 pg selenium. The second dosage form may comprise around 110 pg selenium. The quantities of selenium in this paragraph refer to the mass of selenium atoms in the dosage form. As an example, where the selenium is anhydrous sodium selenite, 110 pg of selenium is provided by 244.4 pg of anhydrous sodium selenite.

[0040] The second dosage form may comprise from 10 to 50 mg zinc and from 10 to 500 pg selenium. The second dosage form may comprise from 15 to 35 mg zinc and from 50 to 200 pg selenium. The second dosage form may comprise from 20 to 30 mg zinc and from 85 to 135 pg selenium.

[0041] The second dosage form is typically for taking in the evening.

[0042] Typically, the second dosage form does not comprise iron. Typically, the second dosage form does not comprise vitamin C. Typically, the second dosage form does not comprise folic acid. Typically, the second dosage form does not comprise vitamin B12. Typically, the second dosage form does not comprise vitamin D

[0043] Kits

[0044] It may be that the kit further comprising instructions directing a subject to take the first dosage form each morning and the second dosage form each evening. For the absence of doubt the dosage forms are each taken daily, in the morning and the evening respectively. The instructions may direct the subject to take the dosage forms for longer than 3 months. The instructions may direct the subject to take the dosage forms for longer than 6 months. The instructions may direct the subject to take the dosage forms for longer than 1 year.

[0045] The kit may comprise an equal amount of the first dosage form and the second dosage form.

[0046] Uses

[0047] The kits of the first aspect of the invention can be used for increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding. Typically, such uses will involve the methods of the third or fourth aspects of the invention.

[0048] Methods

[0049] For the absence of doubt the dosage forms are each taken daily, in the morning and the evening respectively.

[0050] T1 may be longer than 3 months. T1 may be longer than 6 months. T1 may be longer than 1 year. The first dosage form may be administered orally. The second dosage form may be administered orally. Typically, both the first dosage form and the second dosage form are administered orally.

[0051] Hair shedding is indicative of the medical condition ‘telogen effluvium’. Hair loss can be caused by multiple medical conditions including ‘telogen effluvium’, ‘androgenetic alopecia’, ‘alopecia areata’, ‘scarring alopecia’ such as ‘lichenplanopilaris’ and ‘lupus’, chemical / heat related alopecia such as ‘traction alopecia’, ‘trichotillomania’ and ‘Central centrifugal cicatricial alopecia, CCCA’.

[0052] DETAILED DESCRIPTION

[0053] Hair vitamins and minerals selected, and levels needed for hair

[0054] The key vitamins and minerals for hair selected for this invention are iron, vitamin C, folic acid, vitamin B12, vitamin D, selenium and zinc. Biotin has specifically been excluded from the selection.

[0055] Iron

[0056] Ferritin is a protein that stores iron in the body, and it plays a role in various physiological processes, including hair growth. Adequate iron levels are essential for maintaining healthy hair, as iron deficiency can contribute to hair loss and hair shedding.

[0057] The optimal ferritin level for hair health can vary among individuals, and there is no universally agreed-upon "best" level. However, many experts suggest that a ferritin level of at least 70 ng / mL may be beneficial for preventing hair loss / hair shedding and promoting healthy hair growth. Some dermatologists even recommend levels closer to 100 ng / mL.

[0058] The Recommended Dietary Allowance (RDA) for iron in the UK is expressed as the Reference Nutrient Intake (RNI). The RNI represents the amount of a nutrient that is sufficient to meet the needs of nearly all individuals in a population.

[0059] For adults in the UK, the RNI for iron is:

[0060] • For men aged 19-50: 8.7 milligrams per day

[0061] • For women aged 19-50: 14.8 milligrams per day

[0062] Vitamin C - to aid iron absorption

[0063] Vitamin C, also known as ascorbic acid, is essential for collagen synthesis, which is a structural protein that plays a role in the health of the skin, hair, and nails. While vitamin C is important for overall health and can contribute to the strength and vitality of hair, there isn't a specific optimal level solely for hair health.

[0064] The RDA for vitamin C varies by age, sex, and life stage. The UK RDA for vitamin C is as follows:

[0065] • For adults (men and women), the RDA is 40 milligrams per day.

[0066] • During pregnancy, the RDA increases to 50 milligrams per day.

[0067] • While breastfeeding, the RDA further increases to 70 milligrams per day.

[0068] It's worth noting that vitamin C is water-soluble, meaning the body doesn't store it for an extended period, and excess amounts are excreted. Therefore, it's generally safe for most people to obtain vitamin C through a balanced diet that includes fruits and vegetables.

[0069] Vitamin C plays a crucial role in enhancing the absorption of non-heme iron, which is the type of iron found in plant-based foods and iron supplements. There are two main forms of dietary iron: heme iron, found in animal products, and non-heme iron, found in plant-based foods. Non-heme iron is not as easily absorbed by the body as heme iron, but vitamin C can significantly improve its absorption. The mechanism by which vitamin C enhances non-heme iron absorption involves several steps:

[0070] 1 . Reduction of iron: Vitamin C can convert ferric iron (FeA3+) to ferrous iron (FeA2+), which is the more absorbable form of iron. In the digestive system, iron is present in the ferric form, and vitamin C helps to convert it to the ferrous form.

[0071] 2. Chelation of iron: Vitamin C forms a complex with ferrous iron, creating a chelate. This chelate is more easily absorbed in the small intestine compared to non-chelated iron.

[0072] 3. Increased absorption: The chelated iron is transported across the intestinal lining into the bloodstream more efficiently than non-chelated iron, leading to increased iron absorption.

[0073] Consuming vitamin C-rich foods or supplements along with non-heme iron sources, such as beans, lentils, fortified cereals, and leafy green vegetables, can enhance the body's ability to absorb iron. This is particularly important for individuals who follow vegetarian or vegan diets, as the primary source of iron in their diet is non-heme iron.

[0074] Also, taking vitamin C with iron supplements can potentially help reduce gastrointestinal (Gl) side effects and improve the absorption of non-heme iron, which is the type of iron found in plant-based foods and iron supplements.

[0075] Vitamin B12 Vitamin B12 (e.g. methylcobalamin), along with other B-vitamins, plays a role in promoting healthy hair growth. Adequate levels of vitamin B12 are essential for various bodily functions, including the formation of red blood cells, DNA synthesis, and neurological function. Hair follicle cells are also dependent on these processes for normal growth and maintenance. However, there isn't a known specific optimal level of vitamin B12 solely for hair health.

[0076] The UK RDA for vitamin B12 is not specifically defined in the same way as it is in some other countries, such as the United States. Instead, the UK typically refers to Reference Nutrient Intake (RNI) values. For adults in the UK, including men and women, the Reference Nutrient Intake (RNI) for vitamin B12 is approximately 1.5 micrograms per day.

[0077] Folic acid

[0078] Folic acid, also known as vitamin B9, is important for overall health, including the health of your hair. Folic acid plays a role in cell division and the formation of DNA, which are processes that contribute to hair growth. However, there isn't a specific optimal level of folic acid solely for hair health.

[0079] In the UK the RDA for folic acid is the same for men and women who are not pregnant or breastfeeding. The RDA for adults (including men and non-pregnant / non-breastfeeding women) is 200 micrograms (mcg) per day. The recommended daily amount of folic acid for women planning to become pregnant and during the early weeks of pregnancy is 400 micrograms (mcg) per day. It's often advised to start taking a folic acid supplement at least one month before conception and continue through the first 12 weeks of pregnancy.

[0080] Vitamin D

[0081] Vitamin D (e.g. vitamin D3, also known as cholecalciferol) is important for various aspects of health, and some studies suggest a potential link between vitamin D deficiency and hair loss. However, the relationship between vitamin D and hair health is complex, and research is still ongoing to fully understand the mechanisms involved.

[0082] Here are some ways in which vitamin D may be associated with hair health:

[0083] 1. Hair follicle health: Vitamin D receptors are present in hair follicles, suggesting a role in hair growth and maintenance. Adequate vitamin D levels may contribute to the health of the hair follicles. 2. Hair cycling: Vitamin D is involved in the regulation of the hair growth cycle. Insufficient levels of vitamin D might potentially disrupt this cycle and contribute to hair loss.

[0084] 3. Autoimmune conditions: Vitamin D may play a role in modulating the immune system, and some hair loss conditions, such as alopecia areata, have an autoimmune component. Ensuring adequate vitamin D levels may be relevant in these cases.

[0085] The UK RDA for vitamin D is typically expressed in terms of the RNI. For adults and children over the age of one in the UK, the RNI for vitamin D is 10 micrograms (400 International Units) per day.

[0086] Zinc

[0087] Zinc is an essential mineral that plays a role in various physiological processes, and it is important for maintaining healthy hair. Zinc is involved in the synthesis of DNA, RNA, and proteins, including those that contribute to hair structure. Here are some ways in which zinc is related to hair health:

[0088] 1 . Hair growth: Zinc is involved in the process of cell division, which is crucial for the growth and renewal of hair follicle cells. Adequate zinc levels may support healthy hair growth.

[0089] 2. Oil gland function: Zinc helps regulate the function of the sebaceous glands, which are responsible for producing sebum (skin oil). Proper sebum production contributes to the health and moisture balance of the scalp and hair.

[0090] 3. Immune function: Zinc is important for a healthy immune system, and an imbalance in immune function can contribute to certain hair loss conditions. Ensuring sufficient zinc levels may help support a balanced immune response.

[0091] In the UK, the RNI for zinc is approximately 9.5 milligrams per day for men and 7.0 milligrams per day for women.

[0092] Zinc and iron interaction

[0093] Both zinc and iron are important for various physiological functions in the body including hair growth and maintenance, and they are often included in multivitamin supplements. While zinc and iron are often combined together in existing hair multivitamins, high doses of zinc may interfere with the absorption of iron, and vice versa. If you are taking high doses of either mineral, it's advisable to separate their intake by a few hours to minimise potential interactions. Selenium

[0094] Selenium is an essential trace element that plays a role in various physiological processes in the body, including antioxidant defence, thyroid hormone metabolism, and immune system function. While selenium is crucial for overall health, including the health of the hair, the relationship between selenium and hair is not fully understood and can be complex.

[0095] Here are some ways in which selenium may be linked to hair health:

[0096] 1. Antioxidant defence: Selenium is a component of selenoproteins, some of which have antioxidant properties. Antioxidants help protect cells, including those in the hair follicles, from oxidative stress, which can contribute to hair damage and loss.

[0097] 2. Thyroid function: Selenium is important for the proper functioning of the thyroid gland. The thyroid gland produces hormones that play a role in regulating metabolism, including the metabolism of hair follicles. Thyroid disorders can contribute to hair loss.

[0098] 3. Immune system support: Selenium is involved in supporting the immune system, and certain hair loss conditions may have an autoimmune component. Adequate selenium levels may contribute to a balanced immune response.

[0099] There is no known optimal level of selenium for hair. For adults in the UK, the Reference Nutrient Intake (RNI) for selenium is approximately 75 micrograms per day.

[0100] Biotin

[0101] Biotin, also known as vitamin B7, is often promoted as a supplement to improve the health of hair, skin, and nails. While biotin is indeed essential for the metabolism of amino acids and fatty acids, and there is evidence that severe biotin deficiency can lead to hair loss and skin issues, the evidence supporting the use of biotin supplements for improving hair health in individuals without biotin deficiency is limited. While biotin deficiency can lead to hair loss, supplementing with biotin may not necessarily have the same effect in individuals with normal biotin levels. Indeed, the inventors have found that the avoidance of biotin may be beneficial in the dosage forms of the invention.

[0102] Dosage Forms The dosage forms of the invention may be suitable for oral administration. They may be in the form of tablets, caplets, capsules or other forms of solid dosage form. They may be in the form of a liquid dosage form. They may be in the form of a solid dosage form for dissolution in water.

[0103] For tablets, the vitamins and minerals may be admixed with an adjuvant, carrier or bulking agent, for example, lactose, saccharose, sorbitol, mannitol, a starch (for example, potato starch, corn starch or amylopectin, brown rice powder), a cellulose derivative (e.g. microcrystalline cellulose) and dicalcium phosphate; a binder, for example, gelatine or polyvinylpyrrolidone; an antioxidant, for example, tocopherol rich extract, sodium ascorbate; a thickener, for example, gum Arabic, and / or a lubricant / anticaking agent, for example, silicon dioxide, magnesium stearate, calcium stearate, polyethylene glycol, a wax, paraffin, bamboo extract, and the like, and then compressed into tablets. If coated tablets are required, the cores, prepared as described above, may be coated with a concentrated sugar solution which may contain, for example, gum arabic, gelatine, talcum and titanium dioxide. Alternatively, the tablet may be coated with a suitable polymer dissolved in a readily volatile organic solvent.

[0104] For the preparation of soft gelatine capsules, the vitamins and minerals may be admixed with, for example, a vegetable oil or polyethylene glycol. Hard gelatine capsules may contain granules of the vitamins and minerals using either the above-mentioned excipients for tablets. Also liquid or semisolid formulations of the vitamins and minerals may be filled into hard gelatine capsules.

[0105] Liquid preparations for oral application may be in the form of syrups or suspensions, for example, solutions containing the vitamins and minerals, the balance being sugar and a mixture of ethanol, water, glycerol and propylene glycol. Optionally such liquid preparations may contain colouring agents, flavouring agents, sweetening agents (such as saccharine), preservative agents and / or carboxymethylcellulose as a thickening agent or other excipients known to those skilled in art.

[0106] Timing of administration

[0107] Throughout this specification, the term ‘morning’ has its normal meaning. In specific embodiments, it may mean between 6am and midday.

[0108] Throughout this specification, the term ‘evening’ has its normal meaning. In specific embodiments, it may mean between 6pm and midnight. EXAMPLES

[0109] Example 1

[0110] 5 patients took the following dosage forms morning and evening daily for 12+ months:

[0111] • The morning dose comprised of iron 20mg, vitamin C 200mg, vitamin B12 25 pg, folic acid 500pg and vitamin D3 1500 IU. This was in the form of a tablet that contained the following components: Ascorbic Acid; Cholecalciferol (vitamin D3); Thickener: Arabic gum; Antioxidants: Tocopherol Rich Extract, Sodium Ascorbate; Anti-Caking Agent: Silicon Dioxide; Bulking Agent: Corn Syrup Solids, Ferrous Fumarate, Folic acid, Methylcobalamin (vitamin B12).

[0112] • The evening dose comprised of zinc 25mg and selenium 100 pg. This was in the form of a tablet that contained the following components: Dicalcium Phosphate; Microcrystalline Cellulose; Zinc gluconate, Anti-Caking Agent: Magnesium Stearate, Sodium Selenite Anhydrous.

[0113] Method

[0114] Patients were assessed at baseline, 3 months and 1 year.

[0115] Assessment included patient reported measures, clinical assessment by inventor and blood plasma measurements of ferritin, vitamin D, vitamin B12, folic acid and zinc.

[0116] Results

[0117] Ages ranged from 24-82.

[0118] There were 2 males and 3 females included.

[0119] Patients suffered from a range of hair loss conditions including androgenetic alopecia and telogen effluvium.

[0120] Four of the patients were taking market leading hair supplements prior to starting the invention. One patient had been taking Perfectil® by Vitabiotics (containing biotin, iron, vitamin C, folic acid, vitamin B12, vitamin D, zinc and selenium) and three patients had been taking Viviscal™ (containing biotin, iron, zinc, and vitamin C).

[0121] All patients had sub optimal baseline blood plasma levels of hair vitamins and minerals, that improved by 3 months and 1 year assessments.

[0122] All patients had reported, in conjunction with clinical assessment by the inventor, an improvement in their hair shedding and thinning after 3 months. All patients reported an improvement in their Dermatology Quality of Life (DLQI) measures, indicating that their quality of life had improved.

[0123] Conclusion

[0124] Current leading market hair vitamins are failing to deliver adequate hair vitamins and minerals to patients suffering with hair thinning and loss conditions. This could be due to the single tablet ‘multivitamins’ available which impede absorption of key hair minerals such as iron and zinc. Biotin inclusion in currently available hair supplements could be responsible for lack of efficacy. The invention described provides a solution to deliver the key hair vitamins and minerals, in divided morning and evening doses, to achieve optimal levels and clinical efficacy.

[0125] Example 2

[0126] A cohort of patients were taking split dose morning / evening vitamin supplements to treat hair loss conditions in which the morning tablet contained iron (20mg), vitamin C (200mg), vitamin B12 (25 pg), folic acid (500pg) and selenium (110 pg) and the evening tablet contained zinc (25mg) and vitamin D3 (1500 IU).

[0127] Although all patients showed improvement with respect to hair shedding and thinning, two of the cohort experienced headaches and two experienced insomnia.

[0128] The cohort was switched to the dosage forms described in Example 1 . All patients continued to show improvement with respect to hair shedding and thinning but those patients who suffered headaches and insomnia reported that these undesired side-effects ceased.

Claims

CLAIMS1) A kit for increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding; or for treating poor mental health associated with hair thinning, hair loss and / or hair shedding; the kit comprising two dosage forms: a) a first dosage form comprising iron, vitamin C, folic acid, vitamin B12 and vitamin D; and b) a second dosage form comprising selenium and zinc.2) The kit of claim 1 , wherein neither the first dosage form nor the second dosage form comprise biotin.3) The kit of claim 1 or claim 2, further comprising instructions for a subject to take the first dosage form in each morning and the second dosage form each evening.4) The kit of any one of claims 1 to 3, wherein both the first dosage form and the second dosage form are suitable for oral administration.5) The kit of claim 4, wherein both the first dosage form and the second dosage form are tablets.6) A use of the kit of any one of claims 1 to 5 for increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding; or for treating poor mental health associated with hair thinning, hair loss and / or hair shedding.7) A cosmetic method of increasing hair thickness, increasing hair growth, reducing hair thinning, reducing hair loss and / or reducing hair shedding in a subject, the method comprising:• administering a first dosage form each morning for a length of time T1 , said first dosage form comprising: iron, vitamin C, folic acid, vitamin B12 and vitamin D; and• administering a second dosage form each evening for a length of time T 1 , said second dosage form comprising: selenium and zinc.8) A method of treating a condition selected from hair thinning, hair loss, hair shedding and / or poor mental health associated with hair thinning, hair loss and / or hair shedding in a patient in need thereof, the method comprising:• administering a first dosage form each morning for a length of time T1 , said first dosage form comprising: iron, vitamin C, folic acid, vitamin B12 and vitamin D; and• administering a second dosage form each evening for a length of time T 1 , said second dosage form comprising: selenium and zinc.9) The method of claim 7 or claim 8, wherein neither the first dosage form nor the second dosage form comprise biotin.10) The method of any one of claims 7 to 9, wherein T 1 is longer than 3 months.11) The method of any one of claims 7 to 10, wherein both the first dosage form and the second dosage form are administered orally.12) The method of claim 11 , wherein both the first dosage form and the second dosage form are tablets.