Effect of Vitamin D Replacement on Insulin Sensitivity
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Purpose
Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.
| Condition | Intervention | Phase |
|---|---|---|
|
Insulin Sensitivity |
Drug: Ergocalciferols Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency |
- M Value (Insulin Stimulated Glucose Uptake) [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]Insulin stimulated glucose uptake will be measured by glucose clamp studies
| Enrollment: | 12 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin D
ERgocalcifoerol 50,000 units q weekly for 8 weeks
|
Drug: Ergocalciferols
ERgocaclciferol 50,000 units weekly for 8 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
matching placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months
Exclusion Criteria:
1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.
2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.
3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day
Contacts and Locations| United States, Texas | |
| Texas Tech University Health Sciences Center | |
| Odessa, Texas, United States, 79763 | |
| Principal Investigator: | Vinaya Simha, MD | Mayo Clinic |
More Information
Publications:
| Responsible Party: | Vinaya Simha, MD, Associate Professor, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01268111 History of Changes |
| Other Study ID Numbers: | TTUHSC-VitD-RBP4 |
| Study First Received: | December 28, 2010 |
| Results First Received: | January 4, 2013 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Tech University Health Sciences Center:
|
vitamin D deficiency, insulin sensitivity |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Insulin Resistance Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ergocalciferols |
Vitamin D Vitamins Insulin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances Hypoglycemic Agents |
ClinicalTrials.gov processed this record on June 17, 2013