Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
NCT ID: NCT01477801
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
34 participants
INTERVENTIONAL
2011-11-30
2012-09-30
Brief Summary
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1. performance at six minutes walking test
2. echocardiographic parameters
3. neurohormonal imbalance
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CHOLECALCIFEROL
CHOLECALCIFEROL
Standard guideline based therapy plus cholecalciferol:
Loading dose 300.000 U then 50.000 U every month for six months
PLACEBO
PLACEBO
Standard guideline based therapy plus placebo
Interventions
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CHOLECALCIFEROL
Standard guideline based therapy plus cholecalciferol:
Loading dose 300.000 U then 50.000 U every month for six months
PLACEBO
Standard guideline based therapy plus placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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...)
60 Years
ALL
No
Sponsors
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Abiogen Pharma
INDUSTRY
Azienda Unita' Sanitaria Locale Di Modena
OTHER
Responsible Party
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TURRINI FABRIZIO
MD
Principal Investigators
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Fabrizio Turrini, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda USL di Modena
Marco Bondi, MD
Role: STUDY_DIRECTOR
Azienda USL di Modena
Paola Loria, MD
Role: STUDY_CHAIR
Università di Modena
Locations
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Medicina Cardiovascolare - NOCSAE - Azienda USL
Modena, (mo), Italy
Countries
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Central Contacts
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Facility Contacts
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Fabrizio Turrini, MD
Role: primary
Other Identifiers
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2011-001726-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MCV-MO-11-001
Identifier Type: -
Identifier Source: org_study_id