Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Completed; Phase 4

Conditions: Overweight; Insulin Resistance; Obesity

Treatments: Drug: Placebo (for vitamin D); Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02020694

2011-003183-75 (EudraCT Number)

752/11

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Vitamin D and Diet

Experimental group

Description:

Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week. Hypocaloric diet

Treatment:

Drug: Vitamin D

Placebo & Diet

Placebo Comparator group

Description:

Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week. Hypocaloric diet

Treatment:

Drug: Placebo (for vitamin D)