Effect of a Single Colecalciferol Dose on Insulin Resistance

Not Applicable

• Conditions: Insulin Resistance; Glucose Intolerance
• Interventions: Drug: Placebo; Drug: Colecalciferol (Vitamin D3) 300.000 UI

• Registration Number: NCT01075022
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-05
• Status Verified: 2010-02
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Last Update Submitted: 2010-02-23
• Study First Posted: 2010-02-24
• Last Update Posted: 2010-02-24
• Primary Completion: 2010-07
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vitamin D	Colecalciferol (Vitamin D3) 300.000 UI	-

Primary Outcome Measures

Name	Time	Method
Blood Glucose Level	Baseline and day 90

Secondary Outcome Measures

Name	Time	Method
Blood Calcium Level	Baseline and day 90
HOMA-R	Baseline and day 90

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil