Effect of Vitamin D Replacement on Insulin Sensitivity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

ERgocalcifoerol 50,000 units q weekly for 8 weeks

Group Type EXPERIMENTAL

Ergocalciferols

Intervention Type DRUG

ERgocaclciferol 50,000 units weekly for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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Ergocalciferols

ERgocaclciferol 50,000 units weekly for 8 weeks

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes