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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014