Chronic Kidney Failure Clinical Trial
Official title:
Effects of Dietary Supplementation Using Palm Tocotrienols in Chronic Hemodialysis (PATCH) Patients - A Multicenter Study Evaluating Markers of Inflammation, Oxidative Stress and Blood Lipids
This study aims to determine if tocotrienol rich fraction (TRF) supplementation can improve markers of inflammation, oxidative stress and blood lipids in Malaysian hemodialysis (HD) patients.
This study is a multi-centered, randomized, double blind, placebo-controlled trial where a
total of 400 HD patients (200 supplemented; 200 control) will be recruited from government
and private settings. Subjects will be randomized to either the intervention or control
group. The intervention group will receive TRF (300 mg), daily for 12 months while the
control group will only receive placebo, daily for 12 months. In addition, both groups will
receive standard dietary counseling to ensure compliance to medical nutrition therapy
guidelines for dialysis patients.
Patients who consented will be first subjected to a screening for identification of eligible
subjects. The screening will involve basic anthropometry measures (height, weight, BMI),
routine biochemistry result obtained from medical record, assessment of nutritional status
and dietary evaluation. About 15ml of pre-dialysis blood will be collected by respective
nurses for additional laboratory parameters (hsCRP, atherogenic profile and other
inflammatory markers).
Patients who fulfill the inclusion criteria will be randomized to either control or
intervention group. During the 12 months of treatment period, patients in both control and
intervention groups will be assessed at baseline and 3-monthly intervals for laboratory
results, medical condition, hospitalizations, nutritional status, dietary intake and
compliance towards supplementation (intervention group only). A final measurement will be
taken 3 months after study completion as a post follow up assessment upon cessation of
supplementation. In all, patient data will be generated at 6 time points.
(A similar study, following a similar protocol and using the same study design and
intervention will recruit 400 patients total (200 for each group) in Michigan, USA).
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