Effect of Vitamin D Replacement on Insulin Sensitivity

Texas Tech University Health Sciences Center12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Insulin Sensitivity

Interventions

ErgocalciferolsDRUG

ERgocaclciferol 50,000 units weekly for 8 weeks

PlaceboDRUG

matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Texas Tech University Health Sciences Center

Odessa, Texas, United States

Outcomes

Primary Outcomes

M Value (Insulin Stimulated Glucose Uptake)

Insulin stimulated glucose uptake will be measured by glucose clamp studies

Time frame: Baseline and at 8 weeks

Data from ClinicalTrials.gov

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