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

NCT ID: NCT00749918

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Prediabetes Vitamin D Deficiency

Keywords

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vitamin D Cholecalciferol Insulin sensitivity MinMod Millennium FSIGT modified frequently sampled IV glucose tolerance test

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Cholecalciferol (vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.

Interventions

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Cholecalciferol (vitamin D3)

Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol by BIO-TECH Pharmacal, Inc.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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University of Minnesota

Principal Investigators

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Cary Mariash, MD

Role: STUDY_DIRECTOR

University of Minnesota

Shaban Nazarian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Sidney Jones, MD

Role: STUDY_CHAIR

University of Minnesota

Locations

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University of Minnesota, Division of Endocrinology

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0609M92006

Identifier Type: -

Identifier Source: org_study_id