Willingness to avoid direct sun exposure and to restrict travel to sunny climates during the whole study period.Subject has clear understanding of the English language.Subject understands the study procedures and signs the informed consent to participate in the study.Healthy postmenopausal women >50 years in age, who have not experienced a menstrual bleeding for a minimum of 12 months.Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. Using calcifediol seems to be a practical solution, but little is known about the dose response variability in humans and how it compares to that of native vitamin D. This form of vitamin D metabolite has been used historically to increase calcium absorption, treat osteomalacia, and increase Bone Mineral Density (BMD).
Its water solubility may also confer an advantage in patients who have difficulty absorbing fat soluble vitamins.
Calcifediol is also more potent, about 3.5 times more potent in raising 25(OH)D levels than vitamin D. Compared to native vitamin D, calcifediol is more water soluble, has a shorter half-life and increases 25(OH)D levels more quickly. This approach also permits the physician to achieve desired serum levels in a matter of just a few days, rather than the several weeks required when using native vitamin D. One way to circumvent the variability of 25(OH)D response to vitamin D might be to use calcifediol supplementation and bypass the 25-hydroxylase enzyme entirely. Reaching consistent levels of 25(OH)D has been shown to be crucial in decreasing falls, fractures and increasing calcium absorption. Why Should I Register and Submit Results?.
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