Vitamin D Supplementation for the Prevention of Cardiovascular Risk
Primary Purpose
Obesity, Overweight, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Vitamin D
Placebo (for vitamin D)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Insulin resistance, Vitamin D, Cardiovascular risk factors
Eligibility 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
Sites / Locations
- Catholic University of Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D and Diet
Placebo & Diet
Arm Description
Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week. Hypocaloric diet
Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week. Hypocaloric diet
Outcomes
Primary Outcome Measures
Change from baseline in insulin sensitivity (M value)
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
Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).
Change from baseline in body composition
Body composition will be determined by using dual energy X-ray absorptiometry (DXA).
Change from baseline in anthropometric parameters
Weight, BMI, waist and hip circumference, waist/hip ratio.
Change form baseline in systolic and diastolic blood pressure
Change from baseline in phosphocalcic metabolism
Serum vitamin D, PTH and calcium
Change from baseline in inflammatory markers
Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen
Full Information
NCT ID
NCT02020694
First Posted
December 19, 2013
Last Updated
April 17, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT02020694
Brief Title
Vitamin D Supplementation for the Prevention of Cardiovascular Risk
Official Title
The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Insulin Resistance
Keywords
Obesity, Insulin resistance, Vitamin D, Cardiovascular risk factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D and Diet
Arm Type
Experimental
Arm Description
Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week.
Hypocaloric diet
Arm Title
Placebo & Diet
Arm Type
Placebo Comparator
Arm Description
Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week.
Hypocaloric diet
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Type
Drug
Intervention Name(s)
Placebo (for vitamin D)
Primary Outcome Measure Information:
Title
Change from baseline in insulin sensitivity (M value)
Description
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.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change from baseline in oral glucose tolerance
Description
Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).
Time Frame
Baseline, 3 months
Title
Change from baseline in body composition
Description
Body composition will be determined by using dual energy X-ray absorptiometry (DXA).
Time Frame
Baseline, 3 months
Title
Change from baseline in anthropometric parameters
Description
Weight, BMI, waist and hip circumference, waist/hip ratio.
Time Frame
Baseline, 3 months
Title
Change form baseline in systolic and diastolic blood pressure
Time Frame
Baseline, 3 months
Title
Change from baseline in phosphocalcic metabolism
Description
Serum vitamin D, PTH and calcium
Time Frame
Baseline, 3 months
Title
Change from baseline in inflammatory markers
Description
Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Giaccari, MD, PhD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22260937
Citation
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.
Results Reference
background
PubMed Identifier
21209228
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
20587719
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
20150902
Citation
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.
Results Reference
background
PubMed Identifier
29504254
Citation
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.
Results Reference
derived
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Vitamin D Supplementation for the Prevention of Cardiovascular Risk
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