VITAL: VITamin E and Anaemia in dialysis patients in Leeds

Not Applicable

Completed

• Conditions: Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal; Urological and Genital Diseases; Unspecified renal failure

• Registration Number: ISRCTN12650766
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 348

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemoglobin concentration and erythropoeisis stimulating agent requirements at 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Data collected at 6 and 12 months on: <br>1. Markers of oxidative stress<br>2. Fibrin clot structure