Chronic Kidney FailurePATCHNCT02913690
Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)
A study testing TRF in people with Chronic Kidney Failure, run by Wayne State University at 4 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- TRF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 4 sitesMalaysia
- Study dates
- 15 May 2017to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
Hospital Serdang
Kajang, Selangor, 43000
UKM Medical Centre
Kuala Lumpur, Cheras, 56000
Hospital Kuala Lumpur
Kuala Lumpur, 55000
National Kidney Foundation (Malaysia)
Petaling Jaya, Selangor, 46100
About this study
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
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.
Read the 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).
- Conditions
- Chronic Kidney Failure
- Being tested
- Placebo, TRF
- Keywords
- Hemodialysis, Tocotrienol, Vitamin E
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
2 x 150mg capsules daily
TRFDietary supplement
Also called Vitamin E
2 x 150mg capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group will be supplemented with placebo for 12 months. Receives: Dietary Supplement: Placebo |
| Intervention group | Active comparator | The intervention arm will be supplemented with TRF for 12 months. Receives: Dietary Supplement: TRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in inflammatory marker based on the mean change from baseline to 12 months.
Changes in biochemistry marker namely hsCRP (mg/dL)
Measured: Baseline to 12 months
Secondary outcomes (11)
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)
Measured: Baseline to 12 months
Changes in restless leg syndrome scoring
Based on restless leg syndrome questionnaire
Measured: 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)
Measured: 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.
Measured: Baseline to 12 months
Changes in muscle strength
Handgrip strength (in kilogram) will be measured using hand held dynamometer
Measured: 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).
Measured: 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.
Measured: Baseline to 12 months
Changes in nutritional status
Patients will be screened with the Malnutrition Inflammation Score questionnaire to categorize their nutritional status.
Measured: 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.
Measured: Baseline to 12 months
Changes in rate of hospitalisation
Difference in frequency of hospitalisation between the groups during the 12 months will be determined.
Measured: 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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start15 May 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia, Malaysia Palm Oil Board, PEMANDU, National Kidney Foundation, United States, Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Associate Professor Dr Tilakavati Karupaiah, National University of Malaysia
- Investigators
- Tilakavati Karupaiah, PhD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913690
- Sponsor's protocol ID
- NN-041-2015
- Other IDs
- NMRR-14-1859-23386
- Acronym
- PATCH
- Status last verified
- May 2020
- First submitted
- 26 Apr 2016
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24348043Boaz 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.
PubMed 11072938Locatelli 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.
PubMed 11917047Sagheb 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.
PubMed 22317944
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02913690
- Acronym / sponsor ID
- PATCH / NN-041-2015
- Conditions
- Chronic Kidney Failure
- Keywords
- Hemodialysis, Tocotrienol, Vitamin E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia, Malaysia Palm Oil Board, PEMANDU, National Kidney Foundation, United States, Ministry of Health, Malaysia
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: PlaceboControl group will be supplemented with placebo for 12 months. |
| Intervention group | Active comparator | Dietary Supplement: TRFThe intervention arm will be supplemented with TRF for 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 x 150mg capsules daily | Dietary supplement | Control group |
| TRFAlso: Vitamin E2 x 150mg capsules daily | Dietary supplement | Intervention group |
Primary outcome
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)
11 secondary outcomes
Changes in plasma lipids
Time frame: Baseline to 12 months
Changes in restless leg syndrome scoring
Time frame: Baseline to 12 months
Changes in anthropometry measures
Time frame: Baseline to 12 months
Changes in body composition
Time frame: Baseline to 12 months
Changes in muscle strength
Time frame: Baseline to 12 months
Changes in biochemistry parameters
Time frame: Baseline to 12 months
Changes in dietary intake
Time frame: Baseline to 12 months
Changes in nutritional status
Time frame: Baseline to 12 months
Changes in qualify of life (QOL)
Time frame: Baseline to 12 months
Changes in rate of hospitalisation
Time frame: Baseline to 12 months
Changes in metabolomics analyses
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Background: PubMed 24348043Daud 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.
- Background: PubMed 11072938Boaz 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.
- Background: PubMed 11917047Locatelli 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.
- Background: PubMed 22317944Sagheb 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.
- Information on the parallel study conducted in USA by Wayne State UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilakavati Karupaiah, PhD principal investigator
National University of Malaysia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRF in people with Chronic Kidney Failure, run by Wayne State University at 4 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in inflammatory marker based on the mean change from baseline to 12 months. (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913690, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.