Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
Study Overview
Brief Summary
This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.
Detailed Description
A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Impaired fasting glucose
- •Adult, age between 18 and 65
- •Serum vitamin D level below 30 ng/mL
Exclusion Criteria
- •History of nephrolithiasis
- •Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
- •Pregnancy
- •Liver disease
- •Renal disease
Arms & Interventions
1
Each subject was evaluated and data was collected before and after the intervention
Intervention: Cholecalciferol (vitamin D3) (Dietary Supplement)
Outcomes
Primary Outcomes
Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
Time Frame: At baseline and after 4 weeks of vitamin D supplementation
Secondary Outcomes
- Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.(One month)
- Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.(One month)