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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01019642
Enrollment
104
Registered
2009-11-25
Start date
2008-03-31
Completion date
2008-10-31
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Insulin Resistance, Low-intensity Chronic Inflammation

Keywords

vitamin D, diabetes, C-reactive protein, insulin resistance

Brief 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.

Interventions

DRUGcholecalciferol

4,000 IU per day during 6 months. Capsule form.

DRUGplacebo

no active principles given.

Sponsors

Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Ellison Medical / International Nutrition Foundation
CollaboratorUNKNOWN
Tufts University
CollaboratorOTHER
Instituto Nacional de Salud Publica, Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.3 and 6 months
Insulin resistance, measured by HOMA-IR index3 and 6 months

Secondary

MeasureTime frame
Serum 25-OH-vitamin D3 levels3 and 6 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026