Chronic Heart FailurePhase 3NCT01535196
Vitamine D Treatment in Chronic Heart Failure
A Phase 3 study testing Vigantol oil and MCT oil in people with Chronic Heart Failure and Vitamin D Adverse Reaction, run by Semmelweis University at 2 sites in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Heart Failure, Vitamin D Adverse Reaction
- What is being tested?
- Vigantol oil and MCT oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesHungary
- Study dates
- Dec 2012to Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA II-IV
- vitamin D level between 10-30 ng/ml
- ejection fraction by ultrasound < 40 %
Who cannot join
- 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
Show all 9Show fewer
- actual 1,25-OH2-D3 vitamin treatment
- Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation
- serious valve disease
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Semmelweis University Ist Department of Medicine
Budapest, 1083
Semmelweis University Cardiovascular Center
Budapest, 1125
About this study
Official title: 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,
- Conditions
- Chronic Heart Failure, Vitamin D Adverse Reaction
- Being tested
- Vigantol oil and MCT oil
- Keywords
- vitamin D, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigantol oil and MCT oilDrug
Also called no other name
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)
| Study group | Role | What they receive |
|---|---|---|
| 25-OH-D3 vitamin | Experimental | 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 Receives: Drug: Vigantol oil and MCT oil |
| MCT oil | Placebo comparator | 9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol Receives: Drug: Vigantol oil and MCT oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 2 years
Secondary outcomes (5)
D-vitamin supplementation safety
Measured: 1 year
ejection fraction by ultrasound
Measured: 2 years
serum brain natriuretic peptid level
Measured: 2 years
walking test in 6 minutes
Measured: 2 years
well-being score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2017
- Study completionSep 2017
Why it stopped: financial reasons / insufficient enrollment activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Takacs, Semmelweis University
- Investigators
- Istvan Takacs, PhD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535196
- Sponsor's protocol ID
- D-heart
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2012
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial
- ClinicalTrials.gov ID
- NCT01535196
- Acronym / sponsor ID
- D-heart
- Conditions
- Chronic Heart Failure, Vitamin D Adverse Reaction
- Keywords
- vitamin D, heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: financial reasons / insufficient enrollment activity
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25-OH-D3 vitamin | Experimental | Drug: Vigantol oil and MCT oil180 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 |
| MCT oil | Placebo comparator | Drug: Vigantol oil and MCT oil9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA II-IV
- vitamin D level between 10-30 ng/ml
- ejection fraction by ultrasound < 40 %
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigantol oil and MCT oilAlso: no other nameVigantol 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) | Drug | 25-OH-D3 vitamin, MCT oil |
Primary outcome
Survival rate
Time frame: 2 years
5 secondary outcomes
D-vitamin supplementation safety
Time frame: 1 year
ejection fraction by ultrasound
Time frame: 2 years
serum brain natriuretic peptid level
Time frame: 2 years
walking test in 6 minutes
Time frame: 2 years
well-being score
Time frame: 2 years
Results and safety
The study was stopped early (reason given: financial reasons / insufficient enrollment activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Istvan Takacs, PhD principal investigator
Semmelweis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vigantol oil and MCT oil in people with Chronic Heart Failure and Vitamin D Adverse Reaction, run by Semmelweis University at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: financial reasons / insufficient enrollment activity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.