Effect of a Single Colecalciferol Dose on Insulin Resistance

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Insulin Resistance; Glucose Intolerance

Treatments: Drug: Colecalciferol (Vitamin D3) 300.000 UI; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01075022

33598290

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

136 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Treatment:

Drug: Colecalciferol (Vitamin D3) 300.000 UI

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo