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Vitamin D and Mortality in Heart Failure (EVITA)

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

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Vitamin D Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
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
Study Start Date : November 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Changes in biochemical risk markers [ Time Frame: three years ]
    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters

  3. 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.

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.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01326650

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Heart and Diabetes Center North-Rhine Westfalia Identifier: NCT01326650    
Other Study ID Numbers: 004
First Posted: March 31, 2011    Key Record Dates
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamin D
Pharmaceutical Solutions
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents