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Determination of Optimum Vitamin D Nutrition in Young Women

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Annual rept. 30 Sep 2008-29 Sep 2009

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The main objective of this proposal is to study the effect of increasing doses of vitamin D3 in a group of young women with hypovitaminosis D serum 25OHD 20 ngml and an adequate calcium intake of 1200 -1400mgday. This is a double blind randomized placebo controlled study .There will be 5 treatment arms, four vitamin D3 dose groups 400, 800, 1600, 2400 IUday, placebo. Calcium citrate tablets will be given to maintain the calcium intake between 1200-1400mgd. The study will recruit up to 120 Caucasian and 120 African American women subjects, ages 25 to 45. The primary outcomes are changes in serum 25OHD and serum PTH. Secondary outcomes are calcium absorption, physical performance tests and safety measurements of serum calcium and 24 hour urine calcium. The first year of active recruitment started on April 1 2008 and the first subject was randomized to treatment on 04282008. For year one, we had 49 subjects randomized to treatment 20 African Americans, 29 Caucasians. After the first recruitment year we continued to recruit and build a list of potential subjects to contact the next recruitment period. In the second year of recruitment we used these contacts as well as several other methods. Active recruitment for the second year started in January 2009 and to date October 2009 we have randomized to treatment 168 subjects 49 African Americans, 119 Caucasians.

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  • Medicine and Medical Research
  • Food, Food Service and Nutrition

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