Back to resultsEffect of Vitamin D Replacement on Insulin Sensitivity
Primary Purpose
Insulin Sensitivity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferols
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Sensitivity focused on measuring vitamin D deficiency, insulin sensitivity
Eligibility 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
Sites / Locations
- Texas Tech University Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
ERgocalcifoerol 50,000 units q weekly for 8 weeks
Outcomes
Primary Outcome Measures
M Value (Insulin Stimulated Glucose Uptake)
Insulin stimulated glucose uptake will be measured by glucose clamp studies
Secondary Outcome Measures
Full Information
NCT ID
NCT01268111
First Posted
December 28, 2010
Last Updated
May 11, 2015
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT01268111
Brief Title
Effect of Vitamin D Replacement on Insulin Sensitivity
Official Title
Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
Keywords
vitamin D deficiency, insulin sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
ERgocalcifoerol 50,000 units q weekly for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ergocalciferols
Intervention Description
ERgocaclciferol 50,000 units weekly for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
M Value (Insulin Stimulated Glucose Uptake)
Description
Insulin stimulated glucose uptake will be measured by glucose clamp studies
Time Frame
Baseline and at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinaya Simha, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Odessa
State/Province
Texas
ZIP/Postal Code
79763
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23111651
Citation
Simha V, Mahmood M, Ansari M, Spellman CW, Shah P. Effect of vitamin D replacement on insulin sensitivity in subjects with vitamin D deficiency. J Investig Med. 2012 Dec;60(8):1214-8. doi: 10.2310/JIM.0b013e3182747c06.
Results Reference
result
Learn more about this trial
Effect of Vitamin D Replacement on Insulin Sensitivity
We'll reach out to this number within 24 hrs