Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)

Chronic Kidney Failure Clinical Trial

— PATCH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02913690
• Other study ID #: NN-041-2015
• Secondary ID: NMRR-14-1859-233
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: December 14, 2020

Study information

• Verified date: May 2020
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: December 14, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• Placebo
2 x 150mg capsules daily
• TRF
2 x 150mg capsules daily

Locations

Country	Name	City	State
Malaysia	Hospital Serdang	Kajang	Selangor
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	UKM Medical Centre	Kuala Lumpur	Cheras
Malaysia	National Kidney Foundation (Malaysia)	Petaling Jaya	Selangor

Sponsors (6)

Lead Sponsor	Collaborator
Wayne State University	Malaysia Palm Oil Board, Ministry of Health, Malaysia, National Kidney Foundation, PEMANDU, Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

Boaz M, Smetana S, Weinstein T, Matas Z, Gafter U, Iaina A, Knecht A, Weissgarten Y, Brunner D, Fainaru M, Green MS. Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial. Lancet. 2000 Oct 7;356(9237):1213-8. — View Citation

Daud ZA, Tubie B, Sheyman M, Osia R, Adams J, Tubie S, Khosla P. Vitamin E tocotrienol supplementation improves lipid profiles in chronic hemodialysis patients. Vasc Health Risk Manag. 2013;9:747-61. doi: 10.2147/VHRM.S51710. Epub 2013 Nov 28. — View Citation

Locatelli F, Fouque D, Heimburger O, Drüeke TB, Cannata-Andía JB, Hörl WH, Ritz E. Nutritional status in dialysis patients: a European consensus. Nephrol Dial Transplant. 2002 Apr;17(4):563-72. — View Citation

Sagheb MM, Dormanesh B, Fallahzadeh MK, Akbari H, Sohrabi Nazari S, Heydari ST, Behzadi S. Efficacy of vitamins C, E, and their combination for treatment of restless legs syndrome in hemodialysis patients: a randomized, double-blind, placebo-controlled trial. Sleep Med. 2012 May;13(5):542-5. doi: 10.1016/j.sleep.2011.11.010. Epub 2012 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in inflammatory marker based on the mean change from baseline to 12 months.	Changes in biochemistry marker namely hsCRP (mg/dL)	Baseline to 12 months
Secondary	Changes in plasma lipids	Based on biochemistry results for TC, LDL-C, HDL-C, triglyceride (TG), atherogenic profile, cholesteryl ester transfer protein (CETP), lecithin cholesterol acyltransferase (LCAT), apolipoprotein A1(ApoA1), apolipoprotein B-100 (ApoB-100)	Baseline to 12 months
Secondary	Changes in restless leg syndrome scoring	Based on restless leg syndrome questionnaire	Baseline to 12 months
Secondary	Changes in anthropometry measures	This includes body mass index (kg/m2) and skin fold measurements such as mid arm circumference (cm), mid-arm muscle circumference (cm), mid-arm muscle area (cm2) and triceps skin fold (mm)	Baseline to 12 months
Secondary	Changes in body composition	Body composition assessment pertaining to hydration status, lean tissue mass and fat mass is derived using a portable BIA device.	Baseline to 12 months
Secondary	Changes in muscle strength	Handgrip strength (in kilogram) will be measured using hand held dynamometer	Baseline to 12 months
Secondary	Changes in biochemistry parameters	Routine blood parameters (renal, liver function,lipid, hematology profile and dialysis adequacy) will be obtained from patients' medical records. Additional fasted blood sampling will be obtained to determine lipid biomarkers (CETP, LCAT, ApoA1, ApoB-100, lipoprotein particles) as well as inflammation and oxidative stress markers (hs-CRP, IL-6, F-isoprostane).	Baseline to 12 months
Secondary	Changes in dietary intake	Dietary intake will be assessed using a 3-day 24-hr diet recalls to determine macro and micronutrient intake.	Baseline to 12 months
Secondary	Changes in nutritional status	Patients will be screened with the Malnutrition Inflammation Score questionnaire to categorize their nutritional status.	Baseline to 12 months
Secondary	Changes in qualify of life (QOL)	Subjects will be interviewed using SF-36 & KD-QOL questionnaire which will derive QOL score.	Baseline to 12 months
Secondary	Changes in rate of hospitalisation	Difference in frequency of hospitalisation between the groups during the 12 months will be determined.	Baseline to 12 months
Secondary	Changes in metabolomics analyses	Metabolomic analyses (using blood specimens) will be carried out to determine differences in metabolites between the groups.	Baseline to 12 months

External Links

•   Information on the parallel study conducted in USA by Wayne State University