The Effect of Vitamin D Repletion on Insulin Resistance
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|ClinicalTrials.gov Identifier: NCT00606957|
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : October 13, 2011
The reason for doing this study is to learn whether raising a person's vitamin D level from below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D is well known to be an important vitamin for the development and maintenance of bones. Recently, scientists have learned that vitamin D may have a role in the prevention of cancer, diabetes, and autoimmune diseases. The investigators are specifically interested in studying this question in the overweight/obese population as they are at greater risk for both vitamin D deficiency and impaired ability to metabolize sugar (glucose intolerance).
Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.
1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation (directly altering macrophage cytokine production and/or indirectly as a result of improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese population.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Vitamin D3 (cholecalciferol)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Vitamin D Repletion on Insulin Resistance|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- Dietary Supplement: Vitamin D3 (cholecalciferol)
Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.
- The primary outcome is change in insulin sensitivity over time, as measured by the glucose clamp, HOMA and OGTT. [ Time Frame: 14 weeks ]
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): NCT00606957
|United States, New York|
|New York, New York, United States, 10021|
|Principal Investigator:||Allegra Grossman, MD||The Rockefeller University|