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
  Purpose

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.


Condition Intervention
Prediabetes
Vitamin D Deficiency
Dietary Supplement: Cholecalciferol (vitamin D3)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Each subject was evaluated and data was collected before and after the intervention
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00749918

Locations
United States, Minnesota
University of Minnesota, Division of Endocrinology
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minneapolis Medical Research Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: Shaban Nazarian, University of Minnesota
ClinicalTrials.gov Identifier: NCT00749918     History of Changes
Other Study ID Numbers: 0609M92006
Study First Received: September 8, 2008
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
vitamin D
Cholecalciferol
Insulin sensitivity
MinMod Millennium
FSIGT
modified frequently sampled IV glucose tolerance test

Additional relevant MeSH terms:
Vitamin D Deficiency
Glucose Intolerance
Prediabetic State
Insulin Resistance
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperinsulinism
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014