Vitamin D, C-reactive Protein and Insulin Resistance

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus.

The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).

The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: Ellison Medical / International Nutrition Foundation; Instituto Mexicano del Seguro Social; Tufts University
• Treatments: Cholecalciferol; Ergocalciferols; Insulin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus w/ < 10 yrs of diagnosis

• Postmenopausal

• Overweight or obesity (BMI >=25)

• Treated with metformin

Exclusion Criteria:

• BMI >=40

• Liver or kidney disease

• Other important chronic disease: i.e. cancer, autoimmune.

• Receiving insulin