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| ID | Type | Description | Link |
|---|---|---|---|
| NMRR-14-1859-23386 | Other Identifier | Medical Research and Ethics Committee |
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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
| Malaysia Palm Oil Board | OTHER_GOV |
| PEMANDU | UNKNOWN |
| National Kidney Foundation, United States |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group will be supplemented with placebo for 12 months. |
|
| Intervention group | Active Comparator | The intervention arm will be supplemented with TRF for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 2 x 150mg capsules daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in restless leg syndrome scoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tilakavati Karupaiah, PhD | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKM Medical Centre | Kuala Lumpur | Cheras | 56000 | Malaysia | ||
| Hospital Serdang |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24348043 | Background | 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. | |
| 11072938 | Background | 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. doi: 10.1016/s0140-6736(00)02783-5. |
| Label | URL |
|---|---|
| Information on the parallel study conducted in USA by Wayne State University | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Ministry of Health, Malaysia | OTHER_GOV |
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| TRF |
| Dietary Supplement |
2 x 150mg capsules daily |
|
|
Based on restless leg syndrome questionnaire |
| Baseline to 12 months |
| 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 |
| 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 |
| Changes in muscle strength | Handgrip strength (in kilogram) will be measured using hand held dynamometer | Baseline to 12 months |
| 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 |
| 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 |
| Changes in nutritional status | Patients will be screened with the Malnutrition Inflammation Score questionnaire to categorize their nutritional status. | Baseline to 12 months |
| 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 |
| Changes in rate of hospitalisation | Difference in frequency of hospitalisation between the groups during the 12 months will be determined. | Baseline to 12 months |
| 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 |
| Kajang |
| Selangor |
| 43000 |
| Malaysia |
| National Kidney Foundation (Malaysia) | Petaling Jaya | Selangor | 46100 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 55000 | Malaysia |
| 11917047 | Background | Locatelli F, Fouque D, Heimburger O, Drueke TB, Cannata-Andia JB, Horl WH, Ritz E. Nutritional status in dialysis patients: a European consensus. Nephrol Dial Transplant. 2002 Apr;17(4):563-72. doi: 10.1093/ndt/17.4.563. |
| 22317944 | Background | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |