Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism

This study has been completed.
Sponsor:
Collaborator:
Minneapolis Medical Research Foundation
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00749918
First received: September 8, 2008
Last updated: October 16, 2008
Last verified: October 2008

September 8, 2008
October 16, 2008
January 2007
June 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00749918 on ClinicalTrials.gov Archive Site
  • Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
  • Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Prediabetes
  • Vitamin D Deficiency
Dietary Supplement: Cholecalciferol (vitamin D3)
Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.
Other Name: Cholecalciferol by BIO-TECH Pharmacal, Inc.
Experimental: 1
Each subject was evaluated and data was collected before and after the intervention
Intervention: Dietary Supplement: Cholecalciferol (vitamin D3)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00749918
0609M92006
Yes
Shaban Nazarian, University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Minneapolis Medical Research Foundation
Study Director: Cary Mariash, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Shaban Nazarian, MD University of Minnesota - Clinical and Translational Science Institute
Study Chair: Sidney Jones, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP