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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Insulin Resistance; Low-intensity Chronic Inflammation
• Intervention / Treatment: Drug: cholecalciferol; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62450
      • Instituto Mexicano del Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo	Drug: placebo; no active principles given.
Experimental: Vitamin D; Cholecalciferol, 4,000 IU/d for 6 months	Drug: cholecalciferol; 4,000 IU per day during 6 months. Capsule form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.	3 and 6 months
Insulin resistance, measured by HOMA-IR index	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum 25-OH-vitamin D3 levels	3 and 6 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: Tufts University; Instituto Mexicano del Seguro Social; Ellison Medical / International Nutrition Foundation
• Investigators: Principal Investigator: Mario E Flores, MD, MSc, Instituto Nacional de Salud Publica, Mexico

Publications and helpful links

General Publications

• Flores M. A role of vitamin D in low-intensity chronic inflammation and insulin resistance in type 2 diabetes mellitus? Nutr Res Rev. 2005 Dec;18(2):175-82. doi: 10.1079/NRR2005104.
• Munoz-Aguirre P, Flores M, Macias N, Quezada AD, Denova-Gutierrez E, Salmeron J. The effect of vitamin D supplementation on serum lipids in postmenopausal women with diabetes: A randomized controlled trial. Clin Nutr. 2015 Oct;34(5):799-804. doi: 10.1016/j.clnu.2014.10.002. Epub 2014 Oct 13.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 23, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 23, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: diabetes; insulin resistance; vitamin D; C-reactive protein
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Inflammation; Insulin Resistance; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 120-6371