Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT01326650
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2011-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Mortality in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2011-03-30', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who died during the intervention', 'timeFrame': 'three years', 'description': 'all-cause mortality (any cause of death) will be assessed'}], 'secondaryOutcomes': [{'measure': 'Number of event-free survivors', 'timeFrame': 'three years', 'description': 'event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia'}, {'measure': 'Changes in biochemical risk markers', 'timeFrame': 'three years', 'description': 'inflammation markers, kidney parameters, lipid parameters, haemostasis parameters'}, {'measure': 'Number of participants with elevated safety parameters', 'timeFrame': 'every 6 months', 'description': 'Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml.\n\nSerum calcium should not exceed 2.75 mmol/l.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D, mortality, event-free survival, heart failure'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '19359534', 'type': 'BACKGROUND', '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.'}, {'pmid': '19321573', 'type': 'BACKGROUND', '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.'}, {'pmid': '19136901', 'type': 'BACKGROUND', '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.'}, {'pmid': '18304873', 'type': 'BACKGROUND', '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.'}, {'pmid': '18271283', 'type': 'BACKGROUND', '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.'}, {'pmid': '16600924', 'type': 'BACKGROUND', '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.'}, {'pmid': '12570952', 'type': 'BACKGROUND', '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.'}, {'pmid': '30554193', 'type': 'DERIVED', '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.'}, {'pmid': '28835271', 'type': 'DERIVED', '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.'}, {'pmid': '28498942', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age and \\< 80 years of age\n* New York Heart Association Functional Class \\> = II\n\nExclusion Criteria:\n\n* pregnancy and lactation\n* sarcoidosis\n* daily vitamin D intake \\> 20 micrograms\n* serum 25-hydroxyvitamin D \\> 30 ng/ml\n* hypercalcemia'}, 'identificationModule': {'nctId': 'NCT01326650', 'acronym': 'EVITA', 'briefTitle': 'Vitamin D and Mortality in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Heart and Diabetes Center North-Rhine Westfalia'}, 'officialTitle': 'Effect of Vitamin D on All-cause Mortality in Heart Failure Patients', 'orgStudyIdInfo': {'id': '004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'daily vitamin D supplement', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'daily placebo supplement', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['solution of vitamin D oil'], 'description': 'daily oral vitamin D supplement of 100 micrograms for three years', 'armGroupLabels': ['Vitamin D']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['solution of migliol oil'], 'description': 'daily oral placebo supplement for three years', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'state': 'Federal State of North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Heart Center North Rhine-Westphalia', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}], 'overallOfficials': [{'name': 'Armin Zittermann, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Center North Rhine-Westphalia'}, {'name': 'Jochen Börgermann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center North Rhine-Westphalia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart and Diabetes Center North-Rhine Westfalia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}