Vitamine D Treatment in Chronic Heart Failure

Semmelweis University

Status and phase: Terminated; Phase 3

Conditions: Chronic Heart Failure; Vitamin D Adverse Reaction

Treatments: Drug: Vigantol oil and MCT oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01535196

D-heart

Details and patient eligibility

About

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,

Enrollment: 8 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

25-OH-D3 vitamin

Experimental group

Description:

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

Treatment:

Drug: Vigantol oil and MCT oil

MCT oil

Placebo Comparator group

Description:

9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol

Treatment:

Drug: Vigantol oil and MCT oil