Vitamin D Supplementation for the Prevention of Cardiovascular Risk

NCT02020694 | Completed Phase 4

• 2 other identifiers: 752/112011-003183-75
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Insulin Resistance

Keywords

Obesity; Insulin resistance; Vitamin D; Cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months

Secondary Outcomes (6)

• Change from baseline in oral glucose tolerance

  Baseline, 3 months

• Change from baseline in body composition

  Baseline, 3 months

• Change from baseline in anthropometric parameters

  Baseline, 3 months

• Change form baseline in systolic and diastolic blood pressure

  Baseline, 3 months

• Change from baseline in phosphocalcic metabolism

  Baseline, 3 months

Study Arms (2)

Vitamin D and Diet

EXPERIMENTAL

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 & Diet

PLACEBO COMPARATOR

Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week. Hypocaloric diet

Drug: Placebo (for vitamin D)

Interventions

Vitamin D DRUG

Vitamin D and Diet

Placebo (for vitamin D) DRUG

Placebo & Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI≥25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (5)

• 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.

  PMID: 22260937 BACKGROUND

• 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.

  PMID: 21209228 BACKGROUND

• 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.

  PMID: 20587719 BACKGROUND

• 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.

  PMID: 20150902 BACKGROUND

• 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.

  PMID: 29504254 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Insulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andrea Giaccari, MD, PhD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

IT (1)