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Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels (ECSPLOIT -D)

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ClinicalTrials.gov Identifier: NCT01477801
Recruitment Status : Unknown
Verified November 2011 by TURRINI FABRIZIO, Azienda Unita' Sanitaria Locale Di Modena.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : November 23, 2011
Sponsor:
Collaborator:
Abiogen Pharma
Information provided by (Responsible Party):
TURRINI FABRIZIO, 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

Condition or disease Intervention/treatment Phase
Heart Failure Vitamin D Deficiency Drug: CHOLECALCIFEROL Drug: PLACEBO Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study
Study Start Date : November 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHOLECALCIFEROL Drug: CHOLECALCIFEROL

Standard guideline based therapy plus cholecalciferol:

Loading dose 300.000 U then 50.000 U every month for six months

Other Name: DIBASE (ABIOGEN PHARMA)

Placebo Comparator: PLACEBO Drug: PLACEBO
Standard guideline based therapy plus placebo




Primary Outcome Measures :
  1. SIX MINUTE WALKING TEST DISTANCE [ Time Frame: six months ]

Secondary Outcome Measures :
  1. ECHOCARDIOGRAPHIC PARAMETERS [ Time Frame: six months ]
  2. NEUROHORMONAL CHANGES [ Time Frame: six months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477801


Contacts
Contact: Fabrizio Turrini, MD 0039593961100 f.turrini@ausl.mo.it

Locations
Italy
Medicina Cardiovascolare - NOCSAE - Azienda USL Recruiting
Modena, (mo), Italy, 41100
Contact: Fabrizio Turrini, MD    0039593961100    f.turrini@ausl.mo.it   
Sub-Investigator: Stefania Scarlini         
Sponsors and Collaborators
Azienda Unita' Sanitaria Locale Di Modena
Abiogen Pharma
Investigators
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

Responsible Party: TURRINI FABRIZIO, MD, Azienda Unita' Sanitaria Locale Di Modena
ClinicalTrials.gov Identifier: NCT01477801     History of Changes
Other Study ID Numbers: MCV-MO-11-001
2011-001726-14 ( EudraCT Number )
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Heart Failure
Vitamin D Deficiency
Heart Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents