Vitamin D Supplementation for the Prevention of Cardiovascular Risk

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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

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

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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

U.S. FDA Resources

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)

Outcome Measures

Primary Outcome Measures :

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 :

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).
Change from baseline in body composition [ Time Frame: Baseline, 3 months ]
Body composition will be determined by using dual energy X-ray absorptiometry (DXA).
Change from baseline in anthropometric parameters [ Time Frame: Baseline, 3 months ]
Weight, BMI, waist and hip circumference, waist/hip ratio.
Change form baseline in systolic and diastolic blood pressure [ Time Frame: Baseline, 3 months ]
Change from baseline in phosphocalcic metabolism [ Time Frame: Baseline, 3 months ]
Serum vitamin D, PTH and calcium
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

Eligibility Criteria

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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

Contacts and Locations

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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

More Information

Publications:

Muscogiuri G, Policola C, Prioletta A, Sorice G, Mezza T, Lassandro A, Della Casa S, Pontecorvi A, Giaccari A. Low levels of 25(OH)D and insulin-resistance: 2 unrelated features or a cause-effect in PCOS? Clin Nutr. 2012 Aug;31(4):476-80. doi: 10.1016/j.clnu.2011.12.010. Epub 2012 Jan 20.

Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Will vitamin D reduce insulin resistance? Still a long way to go. Am J Clin Nutr. 2011 Mar;93(3):672-3; author reply 673-4. doi: 10.3945/ajcn.110.009068. Epub 2011 Jan 5.

Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Association of vitamin D with insulin resistance and beta-cell dysfunction in subjects at risk for type 2 diabetes: comment to Kayaniyil et al. Diabetes Care. 2010 Jul;33(7):e99; author reply e100. doi: 10.2337/dc10-0587.

Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. 25-Hydroxyvitamin D concentration correlates with insulin-sensitivity and BMI in obesity. Obesity (Silver Spring). 2010 Oct;18(10):1906-10. doi: 10.1038/oby.2010.11. Epub 2010 Feb 11.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cefalo CMA, Conte C, Sorice GP, Moffa S, Sun VA, Cinti F, Salomone E, Muscogiuri G, Brocchi AAG, Pontecorvi A, Mezza T, Giaccari A. Effect of Vitamin D Supplementation on Obesity-Induced Insulin Resistance: A Double-Blind, Randomized, Placebo-Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):651-657. doi: 10.1002/oby.22132. Epub 2018 Mar 4.

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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

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