Effect of a Single Colecalciferol Dose on Insulin Resistance

Hospital de Clinicas de Porto Alegre136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

136

Conditions

Insulin Resistance Glucose Intolerance

Interventions

Colecalciferol (Vitamin D3) 300.000 UIDRUG

Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose

PlaceboDRUG

Placebo Capsule, Single Dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Blood Glucose Level

Time frame: Baseline and day 90

Secondary Outcomes

Blood Calcium Level

Time frame: Baseline and day 90

HOMA-R

Time frame: Baseline and day 90

Data from ClinicalTrials.gov

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