Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Phase 4

Completed

• Conditions: Obesity; Overweight; Insulin Resistance
• Interventions: Drug: Vitamin D; Drug: Placebo (for vitamin D)

• Registration Number: NCT02020694
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D and Diet	Vitamin D	Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week. Hypocaloric diet
Placebo & Diet	Placebo (for vitamin D)	Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week. Hypocaloric diet

Primary Outcome Measures

Name	Time	Method
Change from baseline in insulin sensitivity (M value)	Baseline, 3 months	Insulin sensitivity will be measured with the hyperinsulinemic euglycemic clamp technique and expressed as M value, calculated from the glucose infusion rate during the last 30 min of the clamp.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in oral glucose tolerance	Baseline, 3 months	Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).
Change from baseline in body composition	Baseline, 3 months	Body composition will be determined by using dual energy X-ray absorptiometry (DXA).
Change from baseline in phosphocalcic metabolism	Baseline, 3 months	Serum vitamin D, PTH and calcium
Change from baseline in anthropometric parameters	Baseline, 3 months	Weight, BMI, waist and hip circumference, waist/hip ratio.
Change form baseline in systolic and diastolic blood pressure	Baseline, 3 months
Change from baseline in inflammatory markers	Baseline, 3 months	Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy