search
Back to results

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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Insulin resistance, Vitamin D, Cardiovascular risk factors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 19, 2013
Last Updated
April 17, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

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

Learn more about this trial

Vitamin D Supplementation for the Prevention of Cardiovascular Risk

We'll reach out to this number within 24 hrs