Vitamine D Treatment in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535196
• Other study ID #: D-heart
• Status: Terminated
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: September 2017

Study information

• Verified date: April 2021
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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,

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Vitamin D Adverse Reaction

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Hungary	Semmelweis University Cardiovascular Center	Budapest
Hungary	Semmelweis University Ist Department of Medicine	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		2 years
Secondary	D-vitamin supplementation safety		1 year
Secondary	ejection fraction by ultrasound		2 years
Secondary	serum brain natriuretic peptid level		2 years
Secondary	walking test in 6 minutes		2 years
Secondary	well-being score		2 years