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OpenTrials
Completed

NCT Number: NCT02020694

Vitamin D Supplementation for the Prevention of Cardiovascular Risk

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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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Catholic University of Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Placebo (for vitamin D)

Drug

Primary outcomes

  1. Change from baseline in insulin sensitivity (M value)

    Time frame: 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 outcomes

  1. Change from baseline in oral glucose tolerance

    Time frame: Baseline, 3 months

    Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).

  2. Change from baseline in body composition

    Time frame: Baseline, 3 months

    Body composition will be determined by using dual energy X-ray absorptiometry (DXA).

  3. Change from baseline in anthropometric parameters

    Time frame: Baseline, 3 months

    Weight, BMI, waist and hip circumference, waist/hip ratio.

  4. Change form baseline in systolic and diastolic blood pressure

    Time frame: Baseline, 3 months

  5. Change from baseline in phosphocalcic metabolism

    Time frame: Baseline, 3 months

    Serum vitamin D, PTH and calcium

  6. Change from baseline in inflammatory markers

    Time frame: Baseline, 3 months

    Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 25, 2013
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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