Effect of Vitamin D Replacement on Insulin Sensitivity
Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 24, 2013
CompletedJune 8, 2015
May 1, 2015
1.2 years
December 28, 2010
January 4, 2013
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
M Value (Insulin Stimulated Glucose Uptake)
Insulin stimulated glucose uptake will be measured by glucose clamp studies
Baseline and at 8 weeks
Study Arms (2)
Vitamin D
EXPERIMENTALERgocalcifoerol 50,000 units q weekly for 8 weeks
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months
You may not qualify if:
- \. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.
- \. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University Health Sciences Center
Odessa, Texas, 79763, United States
Related Publications (1)
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.
PMID: 23111651RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- A J Vinaya Simha
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Vinaya Simha, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2010
First Posted
December 29, 2010
Study Start
January 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 8, 2015
Results First Posted
May 24, 2013
Record last verified: 2015-05