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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | ERgocalcifoerol 50,000 units q weekly for 8 weeks |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferols | Drug | ERgocaclciferol 50,000 units weekly for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| M Value (Insulin Stimulated Glucose Uptake) | Insulin stimulated glucose uptake will be measured by glucose clamp studies | Baseline and at 8 weeks |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Vinaya Simha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Odessa | Texas | 79763 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23111651 | Result | Simha V, Mahmood M, Ansari M, Spellman CW, Shah P. Effect of vitamin D replacement on insulin sensitivity in subjects with vitamin D deficiency. J Investig Med. 2012 Dec;60(8):1214-8. doi: 10.2310/JIM.0b013e3182747c06. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | ERgocalcifoerol 50,000 units q weekly for 8 weeks |
| FG001 | Placebo | Matching placebo q weekly for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | ERgocalcifoerol 50,000 units q weekly for 8 weeks |
| BG001 | Placebo | Matching placebo q weekly for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | M Value (Insulin Stimulated Glucose Uptake) | Insulin stimulated glucose uptake will be measured by glucose clamp studies | Posted | Mean | Standard Deviation | mg/kg.min | Baseline and at 8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | ERgocalcifoerol 50,000 units q weekly for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A J Vinaya Simha | Mayo Clinic | 5072664321 | simha.aj@mayo.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Drug |
matching placebo |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Matching placebo q weekly for 8 weeks | 0 | 6 | 0 | 6 |
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| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |