Effect of a Single Colecalciferol Dose on Insulin Resistance

NCT ID: NCT01075022

Last Updated: 2010-02-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-07-31

Brief Summary

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A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.

Detailed Description

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Conditions

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Insulin Resistance Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D

Group Type EXPERIMENTAL

Colecalciferol (Vitamin D3) 300.000 UI

Intervention Type DRUG

Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Capsule, Single Dose

Interventions

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Colecalciferol (Vitamin D3) 300.000 UI

Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose

Intervention Type DRUG

Placebo

Placebo Capsule, Single Dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fasten Blood Glucose \> 100 mg/dL and \< 126 mg/dL
* Age \> 18 years

Exclusion Criteria

* Diabetes Mellitus
* Use of metformin
* Vitamin D Use
* Hypercalcemia
* Chronic Hepatitis
* HIV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clínicas de Porto Alegre

Principal Investigators

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Tania Furlanetto, PhD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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33598290

Identifier Type: -

Identifier Source: org_study_id

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