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A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion

NCT ID: NCT00320853

Last Updated: 2006-05-03

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-05-31

Brief Summary

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The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

Detailed Description

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Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.

Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Vitamin D

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male
* ≥30 years of age
* Waist circumference ≥80 cm

Exclusion Criteria

* Diabetic- Fasting Blood Sugar \>126 mg/dl or on anti-diabetic medication
* BP\>140/90 or on anti-hypertensive medication
* Receiving Vitamin D or calcium supplementation
* Chronic disease-renal/hepatic/malignancy/gastrointestinal
* On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
* Febrile illness or infective morbidity in the past 10 days
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sitaram Bhartia Institute of Science and Research

OTHER

Sponsor Role lead

Principal Investigators

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Jitendra N Pande, MD

Role: PRINCIPAL_INVESTIGATOR

Sitaram Bhartia Institute of Science and Research

Jitender Nagpal, MD

Role: PRINCIPAL_INVESTIGATOR

Sitaram Bhartia Institute of Science and Research

Abhishek Bhartia, ME

Role: STUDY_DIRECTOR

Sitaram Bhartia Institute of Science and Research

Anupama Singh, MD

Role: STUDY_CHAIR

Sitaram Bhartia Institute of Science and Research

Locations

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Sitaram Bhartia Institute of Science and Research

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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SBISR/2006/02

Identifier Type: -

Identifier Source: org_study_id