Palm Tocotrienols in Chronic Hemodialysis (USA)

Summary

Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease, attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention with a naturally occurring dietary supplement may improve certain biomarkers of inflammation and oxidative stress and improve the lipid profile.

Conditions

• End Stage Renal Disease
• Chronic Kidney Disease

Interventions

DIETARY_SUPPLEMENT

TRF (Tocotrienol-rich-fraction)

2 x 150 mg capsules

DIETARY_SUPPLEMENT

Placebo

2 x 150 mg capsules

Sponsors & Collaborators

• DaVita, Inc.

  collaborator INDUSTRY

• Great Lakes Dialysis, LLC

  collaborator OTHER

• National University of Malaysia

  collaborator OTHER

• Universiti Putra Malaysia

  collaborator OTHER

• Ministry of Health, Malaysia

  collaborator OTHER_GOV

• National Kidney Foundation, United States

  collaborator OTHER

• PEMANDU

  collaborator UNKNOWN

• Henry Ford Hospital

  collaborator OTHER

• Kidney Foundation Hospital and Research Institute, Bangladesh

  collaborator OTHER

• Fortis Hospital, India

  collaborator OTHER

• Wayne State University

  lead OTHER

Principal Investigators

• Pramod Khosla, PhD · Wayne State University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-15

Primary Completion

2020-06-30

Completion

2020-08-31

Countries

• United States

Study Locations