VITAL: VITamin E and Anaemia in dialysis patients in Leeds
ISRCTN | ISRCTN12650766 |
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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
Scientific
Department of Renal Medicine
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
Study design | Randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A 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 acronym | VITAL |
Study objectives | Does 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) studied | Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal |
Intervention | Control: Rexeed Dialyser Intervention: Vitabran E dialyser Follow Up Length: 12 month(s) |
Intervention type | Supplement |
Primary outcome measure | Haemoglobin concentration and erythropoeisis stimulating agent requirements at 6 months and 12 months |
Secondary outcome measures | Data collected at 6 and 12 months on: 1. Markers of oxidative stress 2. Fibrin clot structure |
Overall study start date | 01/10/2009 |
Completion date | 01/02/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 348 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/10/2009 |
Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Renal Medicine
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Beckett Street
Leeds
LS9 7TF
England
United Kingdom
Website | http://www.leedsteachinghospitals.com/ |
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https://ror.org/00v4dac24 |
Funders
Funder type
Industry
Asahi Kasei Medical Corporation (Japan)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/03/2014 | Yes | No |
Editorial Notes
20/07/2016: Publication reference added