NCT01019642

Vitamin D, C-reactive Protein and Insulin Resistance

Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Instituto Nacional de Salud Publica, Mexico · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI\>40, autoimmune disease or cancer were not included in the study. Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months. Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month. Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (\~22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels \<80 nmol/L, and 25% were below 40 nmol/L. No one had levels \<20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.

Conditions

• Diabetes
• Low-intensity Chronic Inflammation
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	cholecalciferol	4,000 IU per day during 6 months. Capsule form.
DRUG	placebo	no active principles given.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2009-11-25
• Last updated: 2009-11-25

Locations

1 site across 1 country: Mexico