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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2008

Last Updated Date

October 16, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00749918 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Prediabetes
Vitamin D Deficiency

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1

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

Intervention: Dietary Supplement: Cholecalciferol (vitamin D3)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00749918

Other Study ID Numbers ^ICMJE

0609M92006

Has Data Monitoring Committee

Yes

Responsible Party

Shaban Nazarian, University of Minnesota

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Minneapolis Medical Research Foundation

Investigators ^ICMJE

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

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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