Vitamine D Treatment in Chronic Heart Failure

April 8, 2021 updated by: Istvan Takacs, Semmelweis University

Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial

The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure.

Type of study: Controlled, randomized, double blind, placebo control

Number of patient: 300; 150 treated and 150 placebo controlled

Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month

Duration of study:1+1 year

Primary end points:

Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,

Secondary end points:

Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes

Visits:

Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • 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 Locations

  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University Ist Department of Medicine
      • Budapest, Hungary, 1125
        • Semmelweis University Cardiovascular Center

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NYHA II-IV
  • vitamin D level between 10-30 ng/ml
  • ejection fraction by ultrasound < 40 %

Exclusion Criteria:

  • blood calcium > 2,6 mmol/l
  • urinary calcium > 0,1 mmol/body weight kg/die
  • blood phosphorus > 1,45 mmol/l
  • nephrolithiasis in the history
  • GFR < 30 ml/min
  • vitamin D injection in the last 6 month
  • actual 1,25-OH2-D3 vitamin treatment
  • Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation
  • serious valve disease

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 25-OH-D3 vitamin
180 000 IU 25-OH-D3 vitamin oil per os, per month in the 0, 1, 2, 3, and 6 month at the visit. The patient take the drug under medical control
Drug: Vigantol oil and MCT oil
Vigantol oil, 9 ml, 180 000 IU at the 0,1,2,3,6 month (5 times in the study) MCT oil as placebo, 9 ml, 0,1,2,3,6 month (5 times in the study)
Other Names:
  • no other name
PLACEBO_COMPARATOR: MCT oil
9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol
Drug: Vigantol oil and MCT oil
Vigantol oil, 9 ml, 180 000 IU at the 0,1,2,3,6 month (5 times in the study) MCT oil as placebo, 9 ml, 0,1,2,3,6 month (5 times in the study)
Other Names:
  • no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
D-vitamin supplementation safety
Time Frame: 1 year
1 year
ejection fraction by ultrasound
Time Frame: 2 years
2 years
serum brain natriuretic peptid level
Time Frame: 2 years
2 years
walking test in 6 minutes
Time Frame: 2 years
2 years
well-being score
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Istvan Takacs, PhD, Semmelweis University

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 (ACTUAL)

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-heart

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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