Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Overweight Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Placebo & Diet

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

Hypocaloric diet

Group Type PLACEBO_COMPARATOR

Placebo (for vitamin D)

Intervention Type DRUG

Interventions

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Vitamin D

Intervention Type DRUG

Placebo (for vitamin D)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No