Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism - Full Text View

Sponsors and Collaborators:	University of Minnesota Minneapolis Medical Research Foundation
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00749918

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)

Drug Information available for: Insulin Vitamin D Ergocalciferol Cholecalciferol Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

Further study details as provided by University of Minnesota:

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
1: Experimental 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.

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

Minneapolis Medical Research Foundation

Investigators

Study Director:	Cary Mariash, MD	University of Minnesota
Principal Investigator:	Shaban Nazarian, MD	University of Minnesota
Study Chair:	Sidney Jones, MD	University of Minnesota

More Information

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

Keywords provided by University of Minnesota:

vitamin D
Cholecalciferol
Insulin sensitivity

MinMod Millennium
FSIGT
modified frequently sampled IV glucose tolerance test

Study placed in the following topic categories:

Vitamin D Deficiency
Cholecalciferol
Metabolic Diseases
Avitaminosis
Glucose Intolerance
Ergocalciferols
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases

Insulin
Vitamin D
Malnutrition
Hyperglycemia
Nutrition Disorders
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009