NCT02913690

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

April 26, 2016

Last Update Submit

May 20, 2020

Conditions

Chronic Kidney Failure

Keywords

HemodialysisTocotrienolVitamin E

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Changes in plasma lipids

    Baseline to 12 months

  • Changes in restless leg syndrome scoring

    Baseline to 12 months

  • Changes in anthropometry measures

    Baseline to 12 months

  • Changes in body composition

    Baseline to 12 months

  • Changes in muscle strength

    Baseline to 12 months

  • +6 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group will be supplemented with placebo for 12 months.

Dietary Supplement: Placebo

Intervention group

ACTIVE COMPARATOR

The intervention arm will be supplemented with TRF for 12 months.

Dietary Supplement: TRF

Interventions

PlaceboDIETARY_SUPPLEMENT

2 x 150mg capsules daily

Control group
TRFDIETARY_SUPPLEMENT

2 x 150mg capsules daily

Also known as: Vitamin E
Intervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UKM Medical Centre

Kuala Lumpur, Cheras, 56000, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

Location

National Kidney Foundation (Malaysia)

Petaling Jaya, Selangor, 46100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 55000, Malaysia

Location

Related Publications (4)

  • 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.

    PMID: 24348043BACKGROUND

  • 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.

    PMID: 11072938BACKGROUND

  • 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.

    PMID: 11917047BACKGROUND

  • 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.

    PMID: 22317944BACKGROUND

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tilakavati Karupaiah, PhD

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 26, 2016

First Posted

September 26, 2016

Study Start

May 15, 2017

Primary Completion

June 30, 2020

Study Completion

December 14, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

MY(4)