Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2012-12-31
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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,
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vitamin D Supplementation in Chronic Stable Heart Failure
NCT01292720
Supplementation With Vitamin D to Patients With Heart Failure (D-Heart).
NCT03289637
VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)
NCT03416361
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
NCT01477801
A Trial of Vitamin D Therapy in Patients With Heart Failure
NCT01125436
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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)
MCT oil
9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* vitamin D level between 10-30 ng/ml
* ejection fraction by ultrasound \< 40 %
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Semmelweis University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Istvan Takacs
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Istvan Takacs, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Semmelweis University Ist Department of Medicine
Budapest, , Hungary
Semmelweis University Cardiovascular Center
Budapest, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D-heart
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.