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Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH) (PATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913690
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
Universiti Putra Malaysia
Malaysia Palm Oil Board
PEMANDU
National Kidney Foundation
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Associate Professor Dr Tilakavati Karupaiah, National University of Malaysia

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Failure Dietary Supplement: Placebo Dietary Supplement: TRF Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Changes in restless leg syndrome scoring [ Time Frame: Baseline to 12 months ]
    Based on restless leg syndrome questionnaire

  3. 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)

  4. 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.

  5. Changes in muscle strength [ Time Frame: Baseline to 12 months ]
    Handgrip strength (in kilogram) will be measured using hand held dynamometer

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Malaysia
UKM Medical Centre
Kuala Lumpur, Cheras, Malaysia, 56000
Hospital Serdang
Kajang, Selangor, Malaysia, 43000
National Kidney Foundation (Malaysia)
Petaling Jaya, Selangor, Malaysia, 46100
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 55000
Sponsors and Collaborators
Wayne State University
Universiti Putra Malaysia
Malaysia Palm Oil Board
PEMANDU
National Kidney Foundation
Ministry of Health, Malaysia
Investigators
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Principal Investigator: Tilakavati Karupaiah, PhD National University of Malaysia
Additional Information:
Publications:
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Responsible Party: Associate Professor Dr Tilakavati Karupaiah, Associate Professor, National University of Malaysia
ClinicalTrials.gov Identifier: NCT02913690    
Other Study ID Numbers: NN-041-2015
NMRR-14-1859-23386 ( Other Identifier: Medical Research and Ethics Committee )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Associate Professor Dr Tilakavati Karupaiah, National University of Malaysia:
Hemodialysis
Tocotrienol
Vitamin E
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Vitamin E
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents