the role of vitamin D supplementation in the prevention of cardiovascular risk factors

• Conditions: Obesity; MedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-003183-75-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-23
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

obese subjects aged =18 and =70 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1:fasting plasma glucose = 126 mg/ or who report themselves to have diabetes or who take any oral glucose-lowering medication or insulin 2: resting BP > 140/90 mmHg or those who reported themselves to be hypertensive or those on any antihypertensive medication; 3: cholecalciferol or calcium supplementation in last 6 months; 4:chronic renal, hepatic, malignant or intestinal disease (self reported o r any suggestive medical documents) or renal stones; 5:any medication within the last month that could influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. theophylline, phenytoin, ß -blockers, diuretics, statins or renin–angiotensina system inhibitors, etc.); 6:febrile illness or infective morbidity in the last 10 days; and 7:grossly deranged liver (serum bilirubin > 34 µmol/l and serum glutamic pyruvic transaminase more than four times upper limit of normal) or kidney function (serum creatinine male =1.4 mg/dL (124 µmol/L); female =1.3 mg/dL (115 µmol/L). 8: heart disease and lung 9: primary and secondary hyperparathyroidism.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified