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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01535196
Other study ID # D-heart
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2012
Est. completion date September 2017

Study information

Verified date April 2021
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date September 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

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)

Locations

Country Name City State
Hungary Semmelweis University Cardiovascular Center Budapest
Hungary Semmelweis University Ist Department of Medicine Budapest

Sponsors (1)

Lead Sponsor Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate 2 years
Secondary D-vitamin supplementation safety 1 year
Secondary ejection fraction by ultrasound 2 years
Secondary serum brain natriuretic peptid level 2 years
Secondary walking test in 6 minutes 2 years
Secondary well-being score 2 years
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