Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT02020694

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Insulin Resistance	Drug: Vitamin D Drug: Placebo (for vitamin D)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vitamin D and Diet

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

Drug: Vitamin D

Placebo Comparator: Placebo & Diet

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

Drug: Placebo (for vitamin D)

Outcome Measures

Primary Outcome Measures

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

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 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 phosphocalcic metabolism [Baseline, 3 months]
Serum vitamin D, PTH and calcium
Change from baseline in inflammatory markers [Baseline, 3 months]
Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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