NCT01326650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 11, 2016

Status Verified

September 1, 2015

Enrollment Period

5.7 years

First QC Date

March 29, 2011

Last Update Submit

August 10, 2016

Conditions

Congestive Heart Failure

Keywords

vitamin D, mortality, event-free survival, heart failure

Outcome Measures

Primary Outcomes (1)

  • Number of participants who died during the intervention

    all-cause mortality (any cause of death) will be assessed

    three years

Secondary Outcomes (3)

  • Number of event-free survivors

    three years

  • Changes in biochemical risk markers

    three years

  • Number of participants with elevated safety parameters

    every 6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

daily vitamin D supplement

Drug: Vitamin D

placebo

PLACEBO COMPARATOR

daily placebo supplement

Drug: placebo

Interventions

Vitamin DDRUG

daily oral vitamin D supplement of 100 micrograms for three years

Also known as: solution of vitamin D oil
Vitamin D
placeboDRUG

daily oral placebo supplement for three years

Also known as: solution of migliol oil
placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy and lactation
  • sarcoidosis
  • daily vitamin D intake \> 20 micrograms
  • serum 25-hydroxyvitamin D \> 30 ng/ml
  • hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center North Rhine-Westphalia

Bad Oeynhausen, Federal State of North Rhine-Westphalia, 32545, Germany

Location

Related Publications (10)

  • Zittermann A, Schleithoff SS, Frisch S, Gotting C, Kuhn J, Koertke H, Kleesiek K, Tenderich G, Koerfer R. Circulating calcitriol concentrations and total mortality. Clin Chem. 2009 Jun;55(6):1163-70. doi: 10.1373/clinchem.2008.120006. Epub 2009 Apr 9.

    PMID: 19359534BACKGROUND

  • Zittermann A, Frisch S, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Koertke H, Koerfer R. Vitamin D supplementation enhances the beneficial effects of weight loss on cardiovascular disease risk markers. Am J Clin Nutr. 2009 May;89(5):1321-7. doi: 10.3945/ajcn.2008.27004. Epub 2009 Mar 25.

    PMID: 19321573BACKGROUND

  • Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.

    PMID: 19136901BACKGROUND

  • Zittermann A, Schleithoff SS, Gotting C, Dronow O, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Poor outcome in end-stage heart failure patients with low circulating calcitriol levels. Eur J Heart Fail. 2008 Mar;10(3):321-7. doi: 10.1016/j.ejheart.2008.01.013. Epub 2008 Mar 4.

    PMID: 18304873BACKGROUND

  • Zittermann A, Fischer J, Schleithoff SS, Tenderich G, Fuchs U, Koerfer R. Patients with congestive heart failure and healthy controls differ in vitamin D-associated lifestyle factors. Int J Vitam Nutr Res. 2007 Jul;77(4):280-8. doi: 10.1024/0300-9831.77.4.280.

    PMID: 18271283BACKGROUND

  • Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2006 Apr;83(4):754-9. doi: 10.1093/ajcn/83.4.754.

    PMID: 16600924BACKGROUND

  • Zittermann A, Schleithoff SS, Tenderich G, Berthold HK, Korfer R, Stehle P. Low vitamin D status: a contributing factor in the pathogenesis of congestive heart failure? J Am Coll Cardiol. 2003 Jan 1;41(1):105-12. doi: 10.1016/s0735-1097(02)02624-4.

    PMID: 12570952BACKGROUND

  • Zittermann A, Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Borgermann J, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF. Daily Supplementation with 4000 IU Vitamin D3 for Three Years Does Not Modify Cardiovascular Risk Markers in Patients with Advanced Heart Failure: The Effect of Vitamin D on Mortality in Heart Failure Trial. Ann Nutr Metab. 2019;74(1):62-68. doi: 10.1159/000495662. Epub 2018 Dec 14.

    PMID: 30554193DERIVED

  • Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF, Borgermann J, Zittermann A. Randomized supplementation of 4000 IU vitamin D3 daily vs placebo on the prevalence of anemia in advanced heart failure: the EVITA trial. Nutr J. 2017 Aug 23;16(1):49. doi: 10.1186/s12937-017-0270-5.

    PMID: 28835271DERIVED

  • Zittermann A, Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Birschmann I, Schulz U, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF, Dittrich M, Borgermann J. Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily. Eur Heart J. 2017 Aug 1;38(29):2279-2286. doi: 10.1093/eurheartj/ehx235.

    PMID: 28498942DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Armin Zittermann, PhD

    Heart Center North Rhine-Westphalia

    STUDY CHAIR

  • Jochen Börgermann, MD

    Heart Center North Rhine-Westphalia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2011

First Posted

March 31, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 11, 2016

Record last verified: 2015-09

Locations

DE(1)