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

November 18, 2011 updated by: TURRINI FABRIZIO, Azienda Unita' Sanitaria Locale Di Modena

Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • (mo)
      • Modena, (mo), Italy, 41100
        • Recruiting
        • Medicina Cardiovascolare - NOCSAE - Azienda USL
        • Contact:
        • Sub-Investigator:
          • Stefania Scarlini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Drug: PLACEBO
Standard guideline based therapy plus placebo
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 Names:
  • DIBASE (ABIOGEN PHARMA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SIX MINUTE WALKING TEST DISTANCE
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
ECHOCARDIOGRAPHIC PARAMETERS
Time Frame: six months
six months
NEUROHORMONAL CHANGES
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCV-MO-11-001
  • 2011-001726-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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