Determination of Optimum Vitamin D Nutrition in Young Women
Abstract
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 ng/ml) and an adequate calcium intake of 1200 -1400mg/day. This is a double blind randomized placebo controlled study .There will be 5 treatment arms, four vitamin D3 dose groups (400, 800, 1600, 2400 IU/day, placebo). Calcium citrate tablets will be given to maintain the calcium intake between 1200-1400mg/d. 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 04/28/2008. For year one, we had 49 subjects randomized to treatment (20 African Americans, 29 Caucasians). At the end of the second year of recruitment we have randomized to treatment 168 subjects total (49 African Americans, 119 Caucasians). In the third year of the study we have undertaken numerous recruitment methods to increase African American enrollment. There are 197 subjects total randomized to treatment (78 African Americans, 119 Caucasians). Enrollment of African Americans will have to close on November 1 2010 since we are not able to recruit any more subjects and the study will finish in one year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2010
- Accession Number
- ADA541758
Entities
People
- John C. Gallagher
Organizations
- Creighton University