Effect of Vitamin D Replacement on Insulin Sensitivity

Phase 1

Completed

• Conditions: Insulin Sensitivity
• Interventions: Drug: Ergocalciferols; Drug: Placebo

• Registration Number: NCT01268111
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-28
• Study First Posted: 2010-12-29
• Study Start: 2011-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-01-04
• Results First Submitted QC: 2013-04-18
• Results First Posted: 2013-05-24
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Ergocalciferols	ERgocalcifoerol 50,000 units q weekly for 8 weeks
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
M Value (Insulin Stimulated Glucose Uptake)	Baseline and at 8 weeks	Insulin stimulated glucose uptake will be measured by glucose clamp studies

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Odessa, Texas, United States