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Vitamine D Treatment in Chronic Heart Failure

Primary Purpose

Chronic Heart Failure, Vitamin D Adverse Reaction

Status

Terminated

Phase

Phase 3

Locations

Hungary

Study Type

Interventional

Intervention

Vigantol oil and MCT oil

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring vitamin D, heart failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Semmelweis University Ist Department of Medicine
Semmelweis University Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

25-OH-D3 vitamin

MCT oil

Arm 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

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

Outcomes

Primary Outcome Measures

Survival rate

Secondary Outcome Measures

D-vitamin supplementation safety

ejection fraction by ultrasound

serum brain natriuretic peptid level

walking test in 6 minutes

well-being score

Full Information

NCT ID

NCT01535196

First Posted

January 9, 2012

Last Updated

April 8, 2021

Sponsor

Semmelweis University

1. Study Identification

Unique Protocol Identification Number

NCT01535196

Brief Title

Vitamine D Treatment in Chronic Heart Failure

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

financial reasons / insufficient enrollment activity

Study Start Date

December 2012 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Semmelweis University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure, Vitamin D Adverse Reaction

Keywords

vitamin D, heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

25-OH-D3 vitamin

Arm Type

Experimental

Arm 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

Arm Title

MCT oil

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vigantol oil and MCT oil

Other Intervention Name(s)

no other name

Intervention Description

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)

Primary Outcome Measure Information:

Title

Survival rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

D-vitamin supplementation safety

Time Frame

1 year

Title

ejection fraction by ultrasound

Time Frame

2 years

Title

serum brain natriuretic peptid level

Time Frame

2 years

Title

walking test in 6 minutes

Time Frame

2 years

Title

well-being score

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Istvan Takacs, PhD

Organizational Affiliation

Semmelweis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Semmelweis University Ist Department of Medicine

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Semmelweis University Cardiovascular Center

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

12. IPD Sharing Statement

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Vitamine D Treatment in Chronic Heart Failure

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