Optimizing Vitamin D Nutrition in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT00327847|
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : September 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Oral Vitamin D Supplementation||Not Applicable|
There is ample evidence that improvement in vitamin D nutrition retards bone loss and prevents fractures in the elderly. It is clear that many people living in areas of northern latitude have less than optimal levels of vitamin D. The current recommendations for vitamin D intake are not enough to bring a large majority of the population to the desired adequate level. Furthermore, differences have been observed in the amount of Vitamin D produced in the skin in whites and blacks.
Based on the evidence from literature and our experience from prior studies we hypothesize that:
- the dose of oral vitamin D3 supplement exceeds current recommendations to achieve adequate desired level;
- there may be differences in the dose-response to vitamin D supplement between Blacks and Whites; and
- vitamin D supplementation that produces serum 25-hydroxyvitamin D (25-OHD) levels in the range proposed is safe.
The aims for this pilot study are to determine:
- the average dose of vitamin D3 needed to attain 25-OHD levels between 80-140 nmol/L in a healthy population of mixed races; and
- if there are differences in response to vitamin D3 supplementation between African American and Caucasians subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Optimizing Vitamin D Nutrition in Healthy Adults|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327847
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||John F. Aloia, M.D.||Winthrop University Hospital|