Clinical trial NCT01326650: Vitamin D and Mortality in Heart Failure
Official title: Effect of Vitamin D on All-cause Mortality in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Keywords: vitamin D, mortality, event-free survival, heart failure
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants who died during the intervention
timeFrame: three years
Secondary outcomes:
measure: Number of event-free survivors
timeFrame: three years
measure: Changes in biochemical risk markers
timeFrame: three years
measure: Number of participants with elevated safety parameters
timeFrame: every 6 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart Center North Rhine-Westphalia
state: Federal State of North Rhine-Westphalia
Study officials:
affiliation: Heart Center North Rhine-Westphalia
name: Armin Zittermann, PhD
role: STUDY_CHAIR
affiliation: Heart Center North Rhine-Westphalia
name: Jochen Börgermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.