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Vitamin D Supplementation for the Prevention of Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020694
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Giaccari, Catholic University of the Sacred Heart

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available 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)



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020694


Locations
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Italy
Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Andrea Giaccari, MD, PhD Catholic University of the Sacred Heart
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Giaccari, Associate Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02020694    
Other Study ID Numbers: 752/11
2011-003183-75 ( EudraCT Number )
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015
Keywords provided by Andrea Giaccari, Catholic University of the Sacred Heart:
Obesity
Insulin resistance
Vitamin D
Cardiovascular risk factors
Additional relevant MeSH terms:
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Insulin Resistance
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents