Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
ECSPLOIT -D
2 other identifiers
interventional
34
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Nov 2011
Shorter than P25 for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 23, 2011
November 1, 2011
8 months
November 18, 2011
November 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
SIX MINUTE WALKING TEST DISTANCE
six months
Secondary Outcomes (2)
ECHOCARDIOGRAPHIC PARAMETERS
six months
NEUROHORMONAL CHANGES
six months
Study Arms (2)
CHOLECALCIFEROL
EXPERIMENTALPLACEBO
PLACEBO COMPARATORInterventions
Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months
Eligibility Criteria
You may qualify if:
- Heart failure diagnosis according to European Society of Cardiology Guideline criteria
- Age \> 60 years old
- (OH) Vitamin D level \< 30 ng/ml
- Clinical and therapeutic stability for one month (NYHA class II or III)
You may not qualify if:
- 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...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Unita' Sanitaria Locale Di Modenalead
- Abiogen Pharmacollaborator
Study Sites (1)
Medicina Cardiovascolare - NOCSAE - Azienda USL
Modena, (mo), 41100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrizio Turrini, MD
Azienda USL di Modena
- STUDY DIRECTOR
Marco Bondi, MD
Azienda USL di Modena
- STUDY CHAIR
Paola Loria, MD
Università di Modena
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 23, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
November 23, 2011
Record last verified: 2011-11