Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT00606957
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2008-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D Repletion on Insulin Resistance
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
The Effect of Vitamin D Repletion on Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: