Vitamin D Supplementation for the Prevention of Cardiovascular Risk

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypovitaminosis D is highly prevalent in the general population, particularly in obese individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it has been reported that individuals with low vitamin D levels are at increased risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of these lifestyle interventions. The purpose of this study is to assess whether vitamin D supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• BMI≥25 kg/m2

Exclusion Criteria:

• Diabetes mellitus

• Chronic kidney disease

• Liver disease

• Cholestasis

• Cancer

• Chronic bowel disease

• Primary or secondary hyperparathyroidism

• Treatment with drugs that may affect insulin sensitivity, weight or calcium/vitamin D metabolism

• Laxative abuse

• Changes >10% of usual body weight in the previous 6 months

• Alcohol or illicit drug abuse

• Pregnancy