Effect of Vitamin D Replacement on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01268111
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : May 24, 2013
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Drug: Ergocalciferols Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01268111

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

Publications of Results:
Responsible Party: Texas Tech University Health Sciences Center Identifier: NCT01268111     History of Changes
Other Study ID Numbers: TTUHSC-VitD-RBP4
First Posted: December 29, 2010    Key Record Dates
Results First Posted: May 24, 2013
Last Update Posted: June 8, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Insulin Resistance
Vitamin D Deficiency
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Hypoglycemic Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents