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

This study is currently recruiting participants.
Verified November 2011 by Azienda Unita' Sanitaria Locale Di Modena
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:

U.S. FDA Resources

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 May 16, 2013