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NCT01535196
Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial
Phase 3 trial testing Vigantol oil and MCT oil in Chronic Heart Failure in 8 participants. Terminated before completion.
1 May 2017
Quick facts
| Lead sponsor | Semmelweis University |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 December 2012 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 September 2017 |
| Sites | 2 locations across Hungary |
Drugs / interventions tested
- Vigantol oil and MCT oil — full drug profile →
Conditions studied
- Chronic Heart Failure — all drugs for Chronic Heart Failure →
- Vitamin D Adverse Reaction — all drugs for Vitamin D Adverse Reaction →
Sponsor
Semmelweis University
Who can join
Adults 18 to 99, any sex, with Chronic Heart Failure or Vitamin D Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Survival rate
Time frame: 2 years
Sponsor's own description
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,
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01535196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Heart Failure
Currently open trials in the same condition.
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- NCT07379840 — A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South K · recruiting
- NCT07325942 — Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure · NA · recruiting
- NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
- NCT07405944 — Vericiguat and Reverse Remodeling Indices in Heart Failure · Phase 4 · recruiting
Other Semmelweis University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01535196 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Semmelweis University
- Last refreshed: 8 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01535196.
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