Vitamine D Treatment in Chronic Heart Failure

Study Overview
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Brief Summary
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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,

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

Conditions
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Chronic Heart Failure, Vitamin D Adverse Reaction

Intervention / Treatment
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* Drug: Vigantol oil and MCT oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25-OH-D3 vitamin<br>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 | Drug: Vigantol oil and MCT oil<br>* 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)<br>* Other names: no other name;|
| Placebo Comparator: MCT oil<br>9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol | Drug: Vigantol oil and MCT oil<br>* 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)<br>* Other names: no other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, heart failure