Vitamine D Treatment in Chronic Heart Failure

Phase 3

Terminated

• Conditions: Chronic Heart Failure; Vitamin D Adverse Reaction
• Interventions: Drug: Vigantol oil and MCT oil

• Registration Number: NCT01535196
• Lead Sponsor: Semmelweis University

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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Study Start: 2012-12
• Primary Completion: 2017-05
• Study Completion: 2017-09
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25-OH-D3 vitamin	Vigantol oil and MCT oil	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
MCT oil	Vigantol oil and MCT oil	9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol

Primary Outcome Measures

Name	Time	Method
Survival rate	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Semmelweis University Cardiovascular Center; 🇭🇺 Budapest, Hungary

Semmelweis University Ist Department of Medicine; 🇭🇺 Budapest, Hungary