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| autoid | 90 |
| crg_id | CRG010600027 |
| titleoftrial | Influence of water soluble vitamin supplementation on morbidity and mortality of patients with end-stage renal disease |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Luley |
| leadgivennames | Claus |
| leadposition | Head of Institute |
| leaddepartment | Institute of Clinical Chemistry |
| leadorganisation | University Hospital Magdeburg |
| leadaddress | Leipziger Strasse 44, 39120 Magdeburg, Germany |
| leademail | claus.luley@medizin.uni-magdeburg.de |
| leadphone | +49-391-6713900 |
| leadfax | +49-391-6713902 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Domroese |
| contactgivennames | Ute |
| contactposition | assistant medical director |
| contactdepartment | Internal Medicine, Division of Nephrology |
| contactorganisation | University Hospital Magdeburg |
| contactaddress | Leipziger Strasse 44, 39120 Magdeburg, Germany |
| contactemail | ute.domroese@kfh-dialyse.de |
| contactphone | +49-391-288090 |
| contactfax | +49-391-2880925 |
| funding | other |
| otherfunding | Industry (production of vitamin preparation, personal & laboratory costs) and public funding (personnel and laboratory tests) |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | 07/2002 |
| actualstart | 07/2002 |
| proposedcompletiondate | 07/2006 |
| actualcompletiondate | 12/2007 |
| multi_center_study | yes |
| numberofcentres | 31_35 |
| multi_national_study | no |
| countrycentres | Germany |
| researchquestion | Does watersoluble vitamin supplementation reduce morbidity and mortality in patients with end-stage renal disease? |
| study_status_recruitment | closed |
| study_status_recruitment_follow | closed |
| healthcarecondition | end-stage renal disease |
| intervention1 | watersoluble vitamins (difference in folic acid, vitamin B6, vitamin B12) |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 20 - 80 years |
| totalrecruitment | 620 |
| inclusion | - age 20-80 years
- end-stage renal disease - treatment with hemodialysis |
| exclusion | - addiction to drugs or alcohol
- legal incapacity - missing consent - acute cardiovascular events (6 weeks before enrollment) - pregnancy and lactation - intake of folic acid (other than treatment of acute deficiency) |
| primaryoutcomes | total mortality |
| secondaryoutcomes | mortality and morbidity due to cardiovascular disease
- cardiac infarction - unstable angina pectoris - bypass surgery - sudden cardiac death - stroke - peripheral vascular disease - thrombosis - pulmonary embolism |
| reference | Heinz J, Domrose U, Luley C, Westphal S, Kropf S, Neumann KH, et al. Influence of a supplementation with vitamins on cardiovascular morbidity and mortality in patients with end-stage renal disease: design and baseline data of a randomized clinical trial. Clinical Nephrology 2009 Mar;71(3):363-5. Heinz J, Dierkes J, Domrose U, Neumann KH, Luley C. Influence of a supplementation with vitamins on morbidity and mortality of ESRD patients - a multi-center randomly designed double blinded intervention trial; Prismavit - prospective intervention study from magdeburg with vitamins. XIV Lipid Meeting 2003, Leipzig (Germany), Poster session, Abstract book p.89 Heinz J, Dierkes J, Westphal S, Domr?se U, Neumann KH, Luley C. Lipid lowering therapy with statins in ESRD patients in Germany - baseline data from an ongoing prospective study with vitamins. 1st German Atherosclerosis Symposium 2004, Leipzig (Germany), poster session, Abstract book p. 26 Heinz J, Dierkes J, Martens-Lobenhoffer J, Bode-B?ger SM, Domr?se U, Neumann KH, Luley C. Asymmetric dimethylarginine plasma concentrations in patients with end-stage renal disease and other risk factors. Vascular NO: From Bench to Bedside. An International Symposium 2004, Hannover (Germany), Poster session, Abstract book |