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Vitamin D and Mortality in Heart Failure (EVITA)

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ClinicalTrials.gov Identifier: NCT01326650
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

Tracking Information
First Submitted Date  ICMJE March 29, 2011
First Posted Date  ICMJE March 31, 2011
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
Number of participants who died during the intervention [ Time Frame: three years ]
all-cause mortality (any cause of death) will be assessed
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01326650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Number of event-free survivors [ Time Frame: three years ]
    event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia
  • Changes in biochemical risk markers [ Time Frame: three years ]
    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
  • Number of participants with elevated safety parameters [ Time Frame: every 6 months ]
    Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
  • Number of event-free survivors [ Time Frame: three years ]
    event defined as: death from any course, cardiac transplantation, high urgent listing for cardiac transplantation, rescucitation, hospitalisation, ventricular assist device implantation
  • Changes in biochemical risk markers [ Time Frame: three years ]
    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
  • Number of participants with elevated safety parameters [ Time Frame: every 6 months ]
    Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Mortality in Heart Failure
Official Title  ICMJE Effect of Vitamin D on All-cause Mortality in Heart Failure Patients
Brief Summary Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE
  • Drug: Vitamin D
    daily oral vitamin D supplement of 100 micrograms for three years
    Other Name: solution of vitamin D oil
  • Drug: placebo
    daily oral placebo supplement for three years
    Other Name: solution of migliol oil
Study Arms  ICMJE
  • Experimental: Vitamin D
    daily vitamin D supplement
    Intervention: Drug: Vitamin D
  • Placebo Comparator: placebo
    daily placebo supplement
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
400
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2011)
1000
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • > 18 years of age and < 80 years of age
  • New York Heart Association Functional Class > = II

Exclusion Criteria:

  • pregnancy and lactation
  • sarcoidosis
  • daily vitamin D intake > 20 micrograms
  • serum 25-hydroxyvitamin D > 30 ng/ml
  • hypercalcemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01326650
Other Study ID Numbers  ICMJE 004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heart and Diabetes Center North-Rhine Westfalia
Study Sponsor  ICMJE Heart and Diabetes Center North-Rhine Westfalia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
PRS Account Heart and Diabetes Center North-Rhine Westfalia
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP