Effect of a Single Colecalciferol Dose on Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01075022
• Other study ID #: 33598290
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 23, 2010
• Last updated: February 23, 2010
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2010
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 136
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance

Intervention

Drug:
• Colecalciferol (Vitamin D3) 300.000 UI
Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose
• Placebo
Placebo Capsule, Single Dose

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose Level		Baseline and day 90	No
Secondary	Blood Calcium Level		Baseline and day 90	Yes
Secondary	HOMA-R		Baseline and day 90	No