Evaluation of the effects of chronic treatment with vitamin D in patients with chronic heart failure and low level of vitamin D

• Conditions: CHRONIC HEART FAILURE (NYHA CLASS II-III) VITAMIN D DEFICIT; MedDRA version: 14.1Level: PTClassification code 10006974Term: Calcium metabolism disorderSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10063083Term: Chronic left ventricular failureSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001726-14-IT
• Lead Sponsor: AUSL DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Chronic heart failure; NYHA class II-III - stable in the last three months 2)Age greater than 60 year old 3)Plasma 25(OH) vitamin D less than 30 ng/ml
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1) Chronic use of anticonvulsivants, steroids, digitalis, thiazides 2)glomerular filtration rate lower than30 ml/min/1.73m2 (according to MDRD formula) 3)nefrolithiasia, sarcoidosis and hypercalcemia 4)Coronary acute syndrome or stroke in the previous three months 5) Cancer with prognosis lower than three years 6) Vertebral osteoporotic compression fractures or frequent falls

Study & Design

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