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Trial registered on ANZCTR


Registration number
ACTRN12609000911291
Ethics application status
Approved
Date submitted
24/09/2009
Date registered
16/01/2006
Date last updated
3/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
B-Vitamins and the Risk of total Mortality and Cardiovascular Disease in End-Stage Renal Disease.
Scientific title
Influence of water soluble vitamin supplementation on morbidity and mortality of patients with end-stage renal disease
Secondary ID [1] 986 0
CRG010600027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total mortality and cardiovascular disease in patients with end-stage renal disease 243647 0
Condition category
Condition code
Cardiovascular 252084 252084 0 0
Coronary heart disease
Renal and Urogenital 252085 252085 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
watersoluble vitamins (combined study medication of folic acid 2.5 mg, vitamin B6 10 mg, vitamin B12 25(micro)g; two oral capsule taken three times a week after hemodiaylsis for the study duration (between 2 and 6 years)
(the medication containes additionally vitamin B1 1.2mg, vitamin B2 1.5mg, Niacin 15 mg, Panothenic acid 6mg, Biotin 100(micro)g, Vitamin C 60mg)
Intervention code [1] 241331 0
Treatment: Drugs
Comparator / control treatment
watersoluble vitamins (combined study medication of folic acid 0.1 mg, vitamin B6 0.5 mg, vitamin B12 2(micro)g; two oral capsule taken three times a week after hemodiaylsis for the study duration (between 2 and 6 years)
(the medication containes additionally vitamin B1 1.2mg, vitamin B2 1.5mg, Niacin 15 mg, Panothenic acid 6mg, Biotin 100(micro)g, Vitamin C 60mg)
Control group
Active

Outcomes
Primary outcome [1] 240725 0
Total mortality assessed from clinical data records during monitoring
Timepoint [1] 240725 0
every 12 months for between 2 and 6 years
Secondary outcome [1] 257381 0
Cardiovascular Events (myocardial infarction, unstable angina pectoris, coronary vascularization procedures, sudden cardiac death, stroke, peripheral artery disease, pulmonary embolism, and thromboses (shunt thromboses were not regarded as an endpoint))
Assessment:
Cardiovascular events were identified by reviewing medical records and by consultation with the responsible physicians. Myocardial infarction was diagnosed if at least two of the following criteria had been fulfilled according to standard procedures: clinical status, elevated laboratory parameters (myocardium-specific enzymes, myoglobin), and changes in the electrocardiogram (ECG). Catheterization was performed in cases of suspected myocardial infarction or unstable angina pectoris. Surgical revascularization was carried out after myocardial infarction, in unstable angina pectoris, or where clinical signs had been detected by catheterization and the patients general conditions permitted surgery. Strokes and ischemic insults were verified by computer tomography (CT). Peripheral artery disease was diagnosed according to Fontaines stages or on the basis of by angiographically or sonographically detected >50% stenoses in major arteries and of the lower limbs.
Timepoint [1] 257381 0
every 12 months for between 2 and 6 years

Eligibility
Key inclusion criteria
- age 20-80 years
- end-stage renal disease
- treatment with hemodialysis
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- addiction to drugs or alcohol
- legal incapacity
- missing consent
- acute cardiovascular events (6 weeks before enrollment)
- pregnancy and lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1997 0
Germany
State/province [1] 1997 0

Funding & Sponsors
Funding source category [1] 243779 0
University
Name [1] 243779 0
University Hospital Magdeburg
Address [1] 243779 0
Leipziger Str. 44
D-39120 Magdeburg
Country [1] 243779 0
Germany
Funding source category [2] 243780 0
Commercial sector/Industry
Name [2] 243780 0
Roche Diagnostics
Address [2] 243780 0
Roche Diagnostics GmbH, Sandhofer Str. 116, D-68305 Mannheim, Germany
Country [2] 243780 0
Germany
Funding source category [3] 243902 0
Commercial sector/Industry
Name [3] 243902 0
Fresenius Medical Care
Address [3] 243902 0
Fresenius Medical Care, Else-Kroener-Str. 1 D-61352 Bad Homburg, Germany
Country [3] 243902 0
Germany
Primary sponsor type
Individual
Name
Prof. Dr. C. Luley
Address
Leipziger Str. 44
D-39120 Magdeburg
Country
Germany
Secondary sponsor category [1] 237135 0
Individual
Name [1] 237135 0
Prof. Dr. K.H. Neumann
Address [1] 237135 0
Leipziger Str. 44
D-39120 Magdeburg
Country [1] 237135 0
Germany

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In observational studies hyperhomocysteinemia has been found to be associated with risk for total mortality and cardiovascular events in patients with end-stage renal disease. These patients have grossly elevated homocysteine levels that can be lowered by supplementation with folic acid and vitamin B12.
We therefore conducted a randomized clinical trial with B-vitamins to reduce homocysteine levels and therefore also cardiovascular events and total mortality.
Trial website
Trial related presentations / publications
Heinz J, Domröse U, Luley C, Westphal S, Kropf S, Neumann KH, Dierkes J. 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. Clin Nephrol 2009;71:363-5.

Heinz J, Dierkes J, Domroese 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, Domrese 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-Beger SM, Domrese 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
Public notes

Contacts
Principal investigator
Name 30135 0
Address 30135 0
Country 30135 0
Phone 30135 0
Fax 30135 0
Email 30135 0
Contact person for public queries
Name 13382 0
Prof. Dr. Claus Luley
Address 13382 0
Institute of Clinical Chemistry, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg
Country 13382 0
Germany
Phone 13382 0
0049-391-6713900
Fax 13382 0
Email 13382 0
claus.luley@medizin.uni-magdeburg.de; j.heinz@uke.de
Contact person for scientific queries
Name 4310 0
Dr. Jutta Dierkes
Address 4310 0
Institute of Clinical Chemistry, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg
Country 4310 0
Germany
Phone 4310 0
0049-391-6713900
Fax 4310 0
Email 4310 0
jutta.dierkes@medizin.uni-magdeburg.de

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary