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

Vitamin D Deficiency Clinical Trial

Official title:

Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749918
• Other study ID #: 0609M92006
• Status: Completed
• Phase: N/A
• First received: September 8, 2008
• Last updated: October 16, 2008
• Start date: January 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2008
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetes
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol (vitamin D3)
Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.

Locations

Country	Name	City	State
United States	University of Minnesota, Division of Endocrinology	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.		At baseline and after 4 weeks of vitamin D supplementation	Yes
Secondary	Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.		One month	Yes
Secondary	Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.		One month	Yes