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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749918
First Posted: September 9, 2008
Last Update Posted: October 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Minneapolis Medical Research Foundation
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shaban Nazarian, University of Minnesota
ClinicalTrials.gov Identifier: NCT00749918     History of Changes
Other Study ID Numbers: 0609M92006
First Submitted: September 8, 2008
First Posted: September 9, 2008
Last Update Posted: October 20, 2008
Last Verified: October 2008

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:
Insulin Resistance
Vitamin D Deficiency
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Diabetes Mellitus
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Insulin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hypoglycemic Agents