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Research Project: RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THE SAFETY AND EFFECTIVENESS OF VITAMIN D SUPPLEMENT Project Number: 5306-51530-013-09
Project Type: Reimbursable

Start Date: Oct 01, 2007
End Date: Feb 28, 2009

Objective:
Our interest in this study stems from its use of vitamin D as an intervention to treat probable vitamin D insufficiency and deficiency in African American adolescents. This poor vitamin D status is hypothesized to be a principal contributor to altered calcium metabolism that is negatively affecting bone health in these subjects. In addition to poor vitamin D status, the chronic inflammation of HIV is also postulated to have a detrimental effect on bone turnover in these subjects. In addition, some subjects in the study will be taking an antriretroviral drug (Tenovovir) that appears to have a detrimental effect on vitamin D metabolism, replicating what is seen in non-HIV-infected subjects with impaired kidney function. Thus examination of the interaction of kidney function and inflammation on vitamin D homeostasis in subjects with vitamin D insufficiency is a useful model to predict how subjects with other chronic inflammatory conditions (e.g., metabolic syndrome, type II diabetes) may benefit from vitamin D supplementation. The principal goal of the study is to determine if vitamin D supplements to treat vitamin D deficiency or insufficiency decrease bone turnover associated with chronic inflammation and a drug regimen with toxicity for kidney tubular epithelial cells, where 25OH vitamin D is converted to its active metabolite, calcitriol, for regulation of calcium homeostasis. The subjects in the study are primarily African American adolescents and are at increased risk of vitamin D insufficiency or deficiency due to skin pigmentation, low milk intake, and (possibly) low sun exposure.

Approach:
This is a multi-center study with the Aids Trial Network, a group Dr. Stephensen has worked with previously (when it was known as the REACH network). This is a randomized, placebo-controlled intervention with vitamin D to examine the impact of an ¿adolescent friendly¿ vitamin D supplementation regimen (50,000 IU per month in a single dose) to improve vitamin D status. If successful, this might be a useful approach for subjects at high risk of vitamin D insufficiency or deficiency for whom daily supplements or increased dietary intake of vitamin D are not anticipated to be effective in improving vitamin D status. This study may thus be useful in planning population-based strategies for dealing with the high prevalence of vitamin D deficiency in the US population, particularly in African Americans. Documents Trust with University of Alabama (National Institute of Child Health and Human Development). Log 33840.

   

 
Project Team
Stephensen, Charles
Van Loan, Marta
 
Related National Programs
  Human Nutrition (107)
 
 
Last Modified: 11/05/2008
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