Status:
UNKNOWN
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
Lead Sponsor:
Azienda Unita' Sanitaria Locale Di Modena
Collaborating Sponsors:
Abiogen Pharma
Conditions:
Heart Failure
Vitamin D Deficiency
Eligibility:
All Genders
60+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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...)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01477801
Start Date
November 1 2011
End Date
September 1 2012
Last Update
November 23 2011
Active Locations (1)
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1
Medicina Cardiovascolare - NOCSAE - Azienda USL
Modena, (mo), Italy, 41100