Vitamine D Treatment in Chronic Heart Failure

Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535196

Enrollment

Registered

2012-02-17

Start date

2012-12-31

Completion date

2017-09-30

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Vitamin D Adverse Reaction

Keywords

vitamin D, heart failure

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,

Interventions

DRUGVigantol 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival rate	2 years

Secondary

Measure	Time frame
D-vitamin supplementation safety	1 year
ejection fraction by ultrasound	2 years
serum brain natriuretic peptid level	2 years
walking test in 6 minutes	2 years
well-being score	2 years

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026