Vitamin D Supplementation for the Prevention of Cardiovascular Risk

Obesity Clinical Trial

Official title:

The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020694
• Other study ID #: 752/11
• Secondary ID: 2011-003183-75
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight

Intervention

Drug:
• Vitamin D

• Placebo (for vitamin D)

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in oral glucose tolerance	Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).	Baseline, 3 months
Secondary	Change from baseline in body composition	Body composition will be determined by using dual energy X-ray absorptiometry (DXA).	Baseline, 3 months
Secondary	Change from baseline in anthropometric parameters	Weight, BMI, waist and hip circumference, waist/hip ratio.	Baseline, 3 months
Secondary	Change form baseline in systolic and diastolic blood pressure		Baseline, 3 months
Secondary	Change from baseline in phosphocalcic metabolism	Serum vitamin D, PTH and calcium	Baseline, 3 months
Secondary	Change from baseline in inflammatory markers	Interleukin-6 (IL-6), IL-10, adiponectin, TNF-a, C-reactive protein (CRP) and fibrinogen	Baseline, 3 months