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Sponsored by: |
Rockefeller University |
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Information provided by: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT00606957 |
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).
Primary Hypotheses:
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.
Secondary Hypotheses:
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 | Intervention |
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Obesity |
Dietary Supplement: Vitamin D3 (cholecalciferol) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
Official Title: | The Effect of Vitamin D Repletion on Insulin Resistance |
Estimated Enrollment: | 10 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Rockefeller University | |
New York, New York, United States, 10021 |
Principal Investigator: | Allegra Grossman, MD | The Rockefeller University |
Responsible Party: | The Rockefeller University ( Allegra Grossman, MD ) |
Study ID Numbers: | RUH IRB# AGR-0623 |
Study First Received: | January 22, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00606957 |
Health Authority: | United States: Food and Drug Administration |
Obesity Metabolism |
Cholecalciferol Obesity Metabolic Diseases Ergocalciferols Overweight Insulin Body Weight Hyperinsulinism |
Signs and Symptoms Vitamin D Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic disorder |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |