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Vitamine D Treatment in Chronic Heart Failure

Sponsor
Semmelweis University (Other)
Overall Status
Terminated
CT.gov ID
NCT01535196
Collaborator
(none)
8
Enrollment
2
Locations
2
Arms
57
Actual Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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,

Condition or Disease Intervention/Treatment Phase
  • Drug: Vigantol oil and MCT oil
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survival rate [2 years]

    Secondary Outcome Measures

    1. D-vitamin supplementation safety [1 year]

    2. ejection fraction by ultrasound [2 years]

    3. serum brain natriuretic peptid level [2 years]

    4. walking test in 6 minutes [2 years]

    5. well-being score [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Semmelweis University Ist Department of Medicine Budapest Hungary 1083
    2 Semmelweis University Cardiovascular Center Budapest Hungary 1125

    Sponsors and Collaborators

    • Semmelweis University

    Investigators

    • Principal Investigator: Istvan Takacs, PhD, Semmelweis University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istvan Takacs, Principal investigator, Semmelweis University
    ClinicalTrials.gov Identifier:
    NCT01535196
    Other Study ID Numbers:
    • D-heart
    First Posted:
    Feb 17, 2012
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Istvan Takacs, Principal investigator, Semmelweis University
    vitamin D
    heart failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Apr 13, 2021