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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Simon Lines
Scientific

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

Study design	Randomised interventional treatment trial
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

Participant type(s)	Patient
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

Department of Renal Medicine

Leeds
LS9 7TF
United Kingdom

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

Beckett Street
Leeds
LS9 7TF
England
United Kingdom

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

Industry

Asahi Kasei Medical Corporation (Japan)

No information available

Intention to publish date
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

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

20/07/2016: Publication reference added