Effect of Vitamin D Replacement on Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vinaya Simha, MD, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01268111
First received: December 28, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Insulin Sensitivity
Drug: Ergocalciferols
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • M Value (Insulin Stimulated Glucose Uptake) [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
    Insulin stimulated glucose uptake will be measured by glucose clamp studies


Enrollment: 12
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
ERgocalcifoerol 50,000 units q weekly for 8 weeks
Drug: Ergocalciferols
ERgocaclciferol 50,000 units weekly for 8 weeks
Placebo Comparator: Placebo Drug: Placebo
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268111

Locations
United States, Texas
Texas Tech University Health Sciences Center
Odessa, Texas, United States, 79763
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Vinaya Simha, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Vinaya Simha, MD, Associate Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01268111     History of Changes
Other Study ID Numbers: TTUHSC-VitD-RBP4
Study First Received: December 28, 2010
Results First Received: January 4, 2013
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
vitamin D deficiency, insulin sensitivity

Additional relevant MeSH terms:
Vitamin D Deficiency
Insulin Resistance
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ergocalciferols
Vitamin D
Vitamins
Insulin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 20, 2014