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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Insulin Resistance||Drug: Vitamin D Drug: Placebo (for vitamin D)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
Drug: Vitamin D
Placebo Comparator: Placebo & Diet
Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week.
Drug: Placebo (for vitamin D)
- 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.
- 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
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
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||Andrea Giaccari, MD, PhD||Catholic University of the Sacred Heart|