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Vitamine D Treatment in Chronic Heart Failure

This study is currently recruiting participants.
Verified March 2013 by Semmelweis University
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01535196
First received: January 9, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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

Contacts
Contact: Istvan Takacs, MD, PhD +36-30 4746416 takist@bel1.sote.hu
Contact: Boglarka Szabo, MD +36-20 -6632489 iboglarka@yahoo.com

Locations
Hungary
Semmelweis University Ist Department of Medicine Recruiting
Budapest, Hungary, 1083
Contact: Istvan Takacs, MD, PhD     +36-30 4746416     takist@bel1.sote.hu    
Sub-Investigator: Boglarka Szabo, MD            
Principal Investigator: Istvan Takacs, MD, PhD            
Semmelweis University Cardiovascular Center Recruiting
Budapest, Hungary, 1125
Contact: Boglarka Szabo     +36-20-6632489     iboglarka@yahoo.com    
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: March 20, 2013
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 May 16, 2013