Vitamin D 4,000 IU Tablets, Maximum Strength Vitamin D3 Supplement, 365 Easy to Swallow Tablets - Full Year Supply

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Department of health (DH). (2012). Nutrient analysis of eggs Sampling Report. Nutrient analysis of eggs - Sampling report (publishing.service.gov.uk) Hypervitaminosis D (excess vitamin D) can lead to hypercalcaemia ( a total calcium concentration greater than 2.75 mmol/L), causing deposition of calcium in soft tissues, demineralisation of bones and irreversible renal and cardiovascular toxicity. Hypercalcaemia has been reported at plasma 25(OH)D concentrations above 375-500 nmol/L (SACN, 2016). Hypercalcaemia can also lead to hypercalciuria ( when urinary excretion of calcium exceeds 250 mg/day in women and 275-300 mg/day in men) (EVM, 2003).

Table 2. Estimated total vitamin D exposure from food sources (excluding supplements) in women aged 16-49 years** Hollis BW, Wagner CL. (2004). Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. Am J Clin Nutr. 80(6 Suppl):1752S-8S.Government health advice to reduce sun exposure which can mean less Vitamin D is produced naturally by the body. Public Health England. (2016). Government recommendations for energy and nutrients for males and females aged 1 – 18 years and 19+ years. Main heading (publishing.service.gov.uk)

The most recent NDNS report has shown that between 2016 and 2019 20% of female respondents aged 19-64 years were vitamin D supplement takers (Bates et al., 2020). If you have a diagnosed deficiency (often an incidental finding on a blood test), your doctor might prescribe you a course of high-dose vitamin D, but only for a short period.Dietary vitamin D supplements contain either vitamin D2 or D3, which are synthesised commercially by UVB irradiation of 7-DHC (from sheep wool) and ergosterol (from fungi), respectively (Bikle, 2009). Vitamin D supplements can also be administered by intramuscular injection. In a retrospective study of case reports over a 5-year period, 38 patients aged 0.3-4 years presented with vitamin D intoxication (vomiting, loss of appetite and constipation) and hypercalcemia (mean calcium levels were 3.75 ± 0.5 mmol/L) after consumption of either a prescribed vitamin D3 vial for stoss therapy, non-prescr ibed vitamin D3 vials or incorrectly produced fish oil. The vials contained 7,500 µg (300,000 IU) of vitamin D3; the 9 patients using these vials without prescription were exposed to 15,000-45,000 µg (600,000-2,400,00 IU) of vitamin D. In the 23 patients prescribed these vials for stoss therapy, their exposure was between 15,000-60,000 µg (600,000-I,800,000 IU) of vitamin D. It is unclear how soon after receiving stoss therapy vitamin D intoxication occurred. The patients who had consumed improperly produced fish oil supplements containing 400,000 µg (16,000,000 IU) of vitamin D3 per bottle, were exposed to 25,000-50,000 µg (1,000,000 – 2,000,000 IU). The duration of consumption of the fish oil supplements is unclear. The researchers determined that the minimum dose of vitamin D received causing vitamin D intoxication was 15,000 µg (600,000 IU) and at the time of admission serum 25(OH)D levels were 990 ± 275 nmol/L (396 ± 110 ng/mL) (Çağlar and Çağlar, 2021) . Armas, L.A., Hollis, B.W. and Heaney, R.P.(2004). Vitamin D2 is much less effective than vitamin D3 in humans. The Journal of Clinical Endocrinology & Metabolism, 89(11), pp.5387-5391. There is currently no information on the effect of excess vitamin D during preconception. A number of studies have examined the potential beneficial effects of vitamin D prior to conception. For example, vitamin D intake of up to 10 µg/day (400 IU) and higher blood vitamin D concentrations (between 75 - 125 nmol/L) during preconception have been associated with increased fecundability (Jukic et al., 2019), reduced risk of pregnancy loss (Mumford et al., 2018 abstract only) and reduced risk of gestational diabetes mellitus (Bao et al., 2018). These studies have not been considered further, as such effects are outside the remit of this assessment. However, such supplement studies have not reported obvious adverse effects. Pregnancy In the UK, the main dietary sources of vitamin D are foods of animal origin, fortified foods and supplements (SACN, 2016).

Statement on the potential effects of excess vitamin D intake during preconception, pregnancy and lactation Table A3. Estimated chronic exposure of vitamin D in cultivated mushrooms in women aged 16-49 years**

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Consumption figures sourced from NDNS years 1-8 for cultivated mushrooms. While some of the health claims around vitamin D might have been exaggerated, the buzz around this nutrient isn't without reason. Experts agree it's the one vitamin we should all be taking in the UK, especially during the winter months. Data on the effects of high levels of vitamin D intakes during pregnancy or lactation are limited (SACN, 2016). No adverse effects were observed in 2 studies (Wagner et al., 2006; Hollis et al., 2011) which supplemented pregnant women with vitamin D doses ≥ 100 μg/day (4000 IU). Additionally, the COT previously noted that “serum calcium has not always been measured in such studies and where it was done, hypercalcaemia was not observed” (COT, 2014). However, t here is potential for hypercalcemia to occur during pregnancy in individuals with mutations of genes involved in vitamin D metabolism. Since vitamin D can be synthesised endogenously (in the skin), is metabolised to the active form by the liver and kidney, and can regulate the transcription of vitamin D responsive genes and in turn blood calcium concentration (Morris, 2005), it is often referred to in the literature as a hormone, rather than a vitamin. Vitamin D function and status

Table 4. shows comparisons of vitamin D exposure from different sources: food sources (excluding supplements, supplements only, and food sources (including supplements)). These figures indicate that supplements are likely to be the greatest contributor to vitamin D exposure. It is important to note that consumption estimates of plant-based drinks are based on cow’s milk due to limited number of consumers of plant-based drinks in the NDNS. Additionally, the consumption estimates are based on consumption of cow’s milk on its own, in breakfast cereals and hot beverages such as tea and coffee.The European Food Safety Authority ( EFSA) reviewed vitamin D in 2012 and established a Tolerable Upper Limit (TUL) of 100 µg (4,000 IU) vitamin D per day for adults and 25, 50 and 100 µg/day (1,000, 2,000 and 4,000 IU) vitamin D for infants and children aged up to 12 months, 1-10 years and 11-17 years, respectively. EFSA recognized that vitamin D3 may raise 25(OH)D levels more than vitamin D2, however, as the UL of 100 ug/day was supported by 2 studies both using vitamin D2 and vitamin D3, EFSA’s TUL was considered protective of both forms of vitamin D (D2 and D3). The TUL was also not adjusted to take into account pregnancy or lactation as a TUL is intended to apply to all groups of the general population, including individuals in more sensitive stages of life such as pregnancy. However, the TUL does not cover cases of discrete, identifiable sub-populations who may be especially vulnerable to one or more adverse effects (for example, due to unusual genetic predisposition, certain diseases, or receiving the vitamin under medical supervision) ( EFSA, 2006) . Reynolds, A., O'Connell, S.M., Kenny, L.C. and Dempsey, E. (2017). Transient neonatal hypercalcaemia secondary to excess maternal vitamin D intake: too much of a good thing. Case Reports. pp.bcr-2016. Table 3. Estimated total vitamin D exposure from all dietary sources (including supplements) in women aged 16-49 years. Table 4. Summary of estimated vitamin D exposures from food sources (excluding supplements), supplements and food sources (including supplements) in women aged 16-49 years.