Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH) (PATCH)
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|ClinicalTrials.gov Identifier: NCT02913690|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure||Dietary Supplement: Placebo Dietary Supplement: TRF||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 14, 2020|
Placebo Comparator: Control group
Control group will be supplemented with placebo for 12 months.
Dietary Supplement: Placebo
2 x 150mg capsules daily
Active Comparator: Intervention group
The intervention arm will be supplemented with TRF for 12 months.
Dietary Supplement: TRF
2 x 150mg capsules daily
Other Name: Vitamin E
- Improvement in inflammatory marker based on the mean change from baseline to 12 months. [ Time Frame: Baseline to 12 months ]Changes in biochemistry marker namely hsCRP (mg/dL)
- Changes in plasma lipids [ Time Frame: Baseline to 12 months ]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)
- Changes in restless leg syndrome scoring [ Time Frame: Baseline to 12 months ]Based on restless leg syndrome questionnaire
- Changes in anthropometry measures [ Time Frame: Baseline to 12 months ]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)
- Changes in body composition [ Time Frame: Baseline to 12 months ]Body composition assessment pertaining to hydration status, lean tissue mass and fat mass is derived using a portable BIA device.
- Changes in muscle strength [ Time Frame: Baseline to 12 months ]Handgrip strength (in kilogram) will be measured using hand held dynamometer
- Changes in biochemistry parameters [ Time Frame: Baseline to 12 months ]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).
- Changes in dietary intake [ Time Frame: Baseline to 12 months ]Dietary intake will be assessed using a 3-day 24-hr diet recalls to determine macro and micronutrient intake.
- Changes in nutritional status [ Time Frame: Baseline to 12 months ]Patients will be screened with the Malnutrition Inflammation Score questionnaire to categorize their nutritional status.
- Changes in qualify of life (QOL) [ Time Frame: Baseline to 12 months ]Subjects will be interviewed using SF-36 & KD-QOL questionnaire which will derive QOL score.
- Changes in rate of hospitalisation [ Time Frame: Baseline to 12 months ]Difference in frequency of hospitalisation between the groups during the 12 months will be determined.
- Changes in metabolomics analyses [ Time Frame: Baseline to 12 months ]Metabolomic analyses (using blood specimens) will be carried out to determine differences in metabolites between the groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913690
|UKM Medical Centre|
|Kuala Lumpur, Cheras, Malaysia, 56000|
|Kajang, Selangor, Malaysia, 43000|
|National Kidney Foundation (Malaysia)|
|Petaling Jaya, Selangor, Malaysia, 46100|
|Hospital Kuala Lumpur|
|Kuala Lumpur, Malaysia, 55000|
|Principal Investigator:||Tilakavati Karupaiah, PhD||National University of Malaysia|