Skip to main content
OpenTrials
Completed

NCT Number: NCT01268111

Effect of Vitamin D Replacement on Insulin Sensitivity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Sensitivity Avitaminosis Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Texas Tech University Health Sciences Center

Odessa, Texas, 79763, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.
  • 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

Treatment and study plan

Ergocalciferols

Drug

ERgocaclciferol 50,000 units weekly for 8 weeks

Placebo

Drug

matching placebo

Primary outcomes

  1. M Value (Insulin Stimulated Glucose Uptake)

    Time frame: Baseline and at 8 weeks

    Insulin stimulated glucose uptake will be measured by glucose clamp studies

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.