Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)

Wayne State University

Status

Unknown

Conditions

Chronic Kidney Failure

Treatments

Dietary Supplement: TRF

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02913690

NN-041-2015

NMRR-14-1859-23386 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment

336 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.