Vitamin D, C-reactive Protein and Insulin Resistance

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Low-intensity Chronic Inflammation, Insulin Resistance

Intervention / Treatment
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* Drug: cholecalciferol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, diabetes, C-reactive protein, insulin resistance