Vitamine D Treatment in Chronic Heart Failure

This study has suspended participant recruitment.
(financial reasons)
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01535196
First received: January 9, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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,


Condition Intervention Phase
Chronic Heart Failure
Vitamin D Adverse Reaction
Drug: Vigantol oil and MCT oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial

Resource links provided by NLM:


Further study details as provided by Semmelweis University:

Primary Outcome Measures:
  • Survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • D-vitamin supplementation safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • ejection fraction by ultrasound [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • serum brain natriuretic peptid level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • walking test in 6 minutes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • well-being score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25-OH-D3 vitamin
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
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)
Other Name: no other name
Placebo Comparator: MCT oil
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
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)
Other Name: no other name

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535196

Locations
Hungary
Semmelweis University Ist Department of Medicine
Budapest, Hungary, 1083
Semmelweis University Cardiovascular Center
Budapest, Hungary, 1125
Sponsors and Collaborators
Semmelweis University
Investigators
Principal Investigator: Istvan Takacs, PhD Semmelweis University
  More Information

No publications provided

Responsible Party: Istvan Takacs, Principal investigator, Semmelweis University
ClinicalTrials.gov Identifier: NCT01535196     History of Changes
Other Study ID Numbers: D-heart
Study First Received: January 9, 2012
Last Updated: February 18, 2014
Health Authority: Hungary: Research Ethics Medical Committee

Keywords provided by Semmelweis University:
vitamin D
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014