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Vitamin D and Mortality in Heart Failure (EVITA)

This study has been completed.
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia Identifier:
First received: March 29, 2011
Last updated: August 10, 2016
Last verified: September 2015
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


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

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
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Please refer to this study by its identifier: NCT01326650

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
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
  More Information


Responsible Party: Heart and Diabetes Center North-Rhine Westfalia Identifier: NCT01326650     History of Changes
Other Study ID Numbers: 004
Study First Received: March 29, 2011
Last Updated: August 10, 2016

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
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017