VITAL: VITamin E and Anaemia in dialysis patients in Leeds

ISRCTN ISRCTN12650766
DOI https://doi.org/10.1186/ISRCTN12650766
EudraCT/CTIS number 2009-017505-11
Secondary identifying numbers 6879
Submission date
23/04/2010
Registration date
23/04/2010
Last edited
20/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Lines
Scientific

Department of Renal Medicine
Beckett Street
Leeds
LS9 7TF
United Kingdom

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA study to assess the effects of a vitamin E bonded haemodialysis membrane on erythropoiesis simulating agent requirements and fibrin clot structure and function in chronic haemodialysis patients
Study acronymVITAL
Study objectivesDoes dialysis with a vitamin E bonded haemodialysis membrane reduce erthyropoesis stimulating agent requirements over 12 months in chronic haemodialysis patients?
Ethics approval(s)Leeds (West) Research Ethics Committee (REC) approved on the 26th February 2009 (ref: 08/H1307/144)
Health condition(s) or problem(s) studiedTopic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
InterventionControl: Rexeed Dialyser
Intervention: Vitabran E dialyser

Follow Up Length: 12 month(s)
Intervention typeSupplement
Primary outcome measureHaemoglobin concentration and erythropoeisis stimulating agent requirements at 6 months and 12 months
Secondary outcome measuresData collected at 6 and 12 months on:
1. Markers of oxidative stress
2. Fibrin clot structure
Overall study start date01/10/2009
Completion date01/02/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 348
Key inclusion criteria1. Dialysis patient managed by Leeds Teaching Hospitals NHS Trust Renal Unit
2. Established on HD for at least 3 months prior to entry into study
3. Patients expected to remain on haemodialysis for at least 6 months
4. Written consent and willingness to participate in the study
5. Aged greater than 18 years at point of entry into study
6. Patients on a 3 times a week dialysis schedule
Key exclusion criteria1. Unwillingness or inability to cooperate or give written informed consent
2. Terminally ill patients (expected survival less than 6 months)
3. Medical conditions requiring regular blood transfusion at the time of study enrolment
4. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify from participation
5. Patients with a significant inflammatory illness within 3 months as defined by a C-reactive protein (CRP) greater than 50 mg/L or 3 x patient's baseline CRP
Date of first enrolment01/10/2009
Date of final enrolment01/02/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Renal Medicine
Leeds
LS9 7TF
United Kingdom

Sponsor information

Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Beckett Street
Leeds
LS9 7TF
England
United Kingdom

Website http://www.leedsteachinghospitals.com/
ROR logo "ROR" https://ror.org/00v4dac24

Funders

Funder type

Industry

Asahi Kasei Medical Corporation (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2014 Yes No

Editorial Notes

20/07/2016: Publication reference added