Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
- Registration Number
- NCT01477801
- Lead Sponsor
- Azienda Unita' Sanitaria Locale Di Modena
- Brief Summary
The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:
1. performance at six minutes walking test
2. echocardiographic parameters
3. neurohormonal imbalance
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Heart failure diagnosis according to European Society of Cardiology Guideline criteria
- Age > 60 years old
- 25(OH) Vitamin D level < 30 ng/ml
- Clinical and therapeutic stability for one month (NYHA class II or III)
Exclusion Criteria
- Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
- Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
- Nephrolitiasis, Sarcoidosis or hypercalcemia
- Recent (three months) acute coronary syndrome or stroke or major vascular surgery
- Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PLACEBO PLACEBO - CHOLECALCIFEROL CHOLECALCIFEROL -
- Primary Outcome Measures
Name Time Method SIX MINUTE WALKING TEST DISTANCE six months
- Secondary Outcome Measures
Name Time Method ECHOCARDIOGRAPHIC PARAMETERS six months NEUROHORMONAL CHANGES six months
Trial Locations
- Locations (1)
Medicina Cardiovascolare - NOCSAE - Azienda USL
🇮🇹Modena, (mo), Italy