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

Primary Purpose

Prediabetes, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol (vitamin D3)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring vitamin D, Cholecalciferol, Insulin sensitivity, MinMod Millennium, FSIGT, modified frequently sampled IV glucose tolerance test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota, Division of Endocrinology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Each subject was evaluated and data was collected before and after the intervention

Outcomes

Primary Outcome Measures

Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.

Secondary Outcome Measures

Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.
Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.

Full Information

First Posted
September 8, 2008
Last Updated
October 16, 2008
Sponsor
University of Minnesota
Collaborators
Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00749918
Brief Title
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
Official Title
Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota
Collaborators
Hennepin Healthcare Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Vitamin D Deficiency
Keywords
vitamin D, Cholecalciferol, Insulin sensitivity, MinMod Millennium, FSIGT, modified frequently sampled IV glucose tolerance test

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Each subject was evaluated and data was collected before and after the intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol (vitamin D3)
Other Intervention Name(s)
Cholecalciferol by BIO-TECH Pharmacal, Inc.
Intervention Description
Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cary Mariash, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaban Nazarian, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sidney Jones, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota, Division of Endocrinology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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