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Effect of Vitamin D Replacement on Insulin Sensitivity

This study has been completed.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center Identifier:
First received: December 28, 2010
Last updated: May 11, 2015
Last verified: May 2015
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
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

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 ]
    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


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

  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Texas Tech University Health Sciences Center 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: May 11, 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 processed this record on September 21, 2017