Clinical trial NCT02020694: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Overweight
Insulin Resistance
Keywords: Obesity
Insulin resistance
Vitamin D
Cardiovascular risk factors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline in insulin sensitivity (M value)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change from baseline in oral glucose tolerance
timeFrame: Baseline, 3 months
measure: Change from baseline in body composition
timeFrame: Baseline, 3 months
measure: Change from baseline in anthropometric parameters
timeFrame: Baseline, 3 months
measure: Change form baseline in systolic and diastolic blood pressure
timeFrame: Baseline, 3 months
measure: Change from baseline in phosphocalcic metabolism
timeFrame: Baseline, 3 months
measure: Change from baseline in inflammatory markers
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Andrea Giaccari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.