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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Azienda Unita' Sanitaria Locale Di Modena.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abiogen Pharma
Information provided by (Responsible Party):
TURRINI FABRIZIO, Azienda Unita' Sanitaria Locale Di Modena
ClinicalTrials.gov Identifier:
NCT01477801
First received: November 18, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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 Intervention Phase
Heart Failure
Vitamin D Deficiency
Drug: CHOLECALCIFEROL
Drug: PLACEBO
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Azienda Unita' Sanitaria Locale Di Modena:

Primary Outcome Measures:
  • SIX MINUTE WALKING TEST DISTANCE [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ECHOCARDIOGRAPHIC PARAMETERS [ Time Frame: six months ] [ Designated as safety issue: No ]
  • NEUROHORMONAL CHANGES [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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...)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 18, 2011
Last Updated: November 18, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014