Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)

Wayne State University336 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

336

Conditions

Chronic Kidney Failure

Interventions

PlaceboDIETARY_SUPPLEMENT

2 x 150mg capsules daily

TRFDIETARY_SUPPLEMENT

2 x 150mg capsules daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provided consent and comply to study protocol * Undergoing HD treatment thrice-weekly for \> 3 months * Adequately dialyzed (Kt/V\> 1.2 or urea reduction ratio (URR) of 65%) and hsCRP level \<20 mg/dL. Exclusion Criteria: * Participated in another clinical trial involving an investigational product in the past 12 weeks preceding enrolment. * Planned for kidney transplant over the study duration. * Intake of vitamin E-containing supplements (\>60 IU/day) 30 days preceding enrolment. * Intake of anti-inflammatory medication except aspirin \<325 mg/day in the past 30 days preceding enrollment. * Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial. * Poor adherence to HD or medical treatment * Patient with temporary catheter for dialysis access at baseline, or patients receiving graft/fistula within the 6-month study period. * History of hospitalizations (\>2 times within the past 90 days or one hospitalization within the 30 days) preceding enrollment. * Receiving nutritional support ( via enteral and intra-venous route). * Diagnosed with HIV/AIDS and/or on the anti-HIV therapy * Receiving active treatment for cancer (excluding basal cell carcinoma of the skin). * Patients with Hepatitis B or C. * Any other significant disease or disorder where in the opinion of the respective nephrologist may affect the end results of this study * Patients with a known allergy towards fish.

Locations (4)

UKM Medical Centre

Kuala Lumpur, Cheras, Malaysia

Hospital Serdang

Kajang, Selangor, Malaysia

National Kidney Foundation (Malaysia)

Petaling Jaya, Selangor, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia