Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
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
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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
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 May 19, 2013