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Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels

NCT01477801 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-11-23

No results posted yet for this study

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

Conditions

Interventions

DRUG

CHOLECALCIFEROL

Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months

DRUG

PLACEBO

Standard guideline based therapy plus placebo

Sponsors & Collaborators

  • Abiogen Pharma

    collaborator INDUSTRY

  • Azienda Unita' Sanitaria Locale Di Modena

    lead OTHER

Principal Investigators

  • Fabrizio Turrini, MD · Azienda USL di Modena

  • Marco Bondi, MD · Azienda USL di Modena

  • Paola Loria, MD · Università di Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477801 on ClinicalTrials.gov