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financial reasons / insufficient enrollment activity
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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25-OH-D3 vitamin | Experimental | 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 | Placebo Comparator | 9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigantol oil and MCT oil | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| D-vitamin supplementation safety | 1 year | |
| ejection fraction by ultrasound | 2 years | |
| serum brain natriuretic peptid level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Istvan Takacs, PhD | Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Ist Department of Medicine | Budapest | 1083 | Hungary | |||
| Semmelweis University Cardiovascular Center |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 2 years |
| walking test in 6 minutes | 2 years |
| well-being score | 2 years |
| Budapest |
| 1125 |
| Hungary |