Vitamin D, C-reactive Protein and Insulin Resistance

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019642
• Other study ID #: 120-6371
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2009
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes
• Inflammation
• Insulin Resistance
• Low-intensity Chronic Inflammation

Intervention

Drug:
• cholecalciferol
4,000 IU per day during 6 months. Capsule form.
• placebo
no active principles given.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Cuernavaca	Morelos

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	Ellison Medical / International Nutrition Foundation, Instituto Mexicano del Seguro Social, Tufts University

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.		3 and 6 months	No
Primary	Insulin resistance, measured by HOMA-IR index		3 and 6 months	No
Secondary	Serum 25-OH-vitamin D3 levels		3 and 6 months	Yes