We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D and Mortality in Heart Failure (EVITA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326650
First Posted: March 31, 2011
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
  Purpose
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.

Condition Intervention Phase
Congestive Heart Failure Drug: Vitamin D Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • Number of participants who died during the intervention [ Time Frame: three years ]
    all-cause mortality (any cause of death) will be assessed


Secondary Outcome Measures:
  • 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.



Enrollment: 400
Study Start Date: November 2010
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
daily vitamin D supplement
Drug: Vitamin D
daily oral vitamin D supplement of 100 micrograms for three years
Other Name: solution of vitamin D oil
Placebo Comparator: placebo
daily placebo supplement
Drug: placebo
daily oral placebo supplement for three years
Other Name: solution of migliol oil

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326650


Locations
Germany
Heart Center North Rhine-Westphalia
Bad Oeynhausen, Federal State of North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
  More Information

Publications:

Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01326650     History of Changes
Other Study ID Numbers: 004
First Submitted: March 29, 2011
First Posted: March 31, 2011
Last Update Posted: August 11, 2016
Last Verified: September 2015

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
vitamin D, mortality, event-free survival, heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents