Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Palm Tocotrienols in Chronic Hemodialysis (Malaysia) (PATCH)

NCT02913690

Chronic Kidney Failure

UNKNOWN NA

Palm Tocotrienols in Chronic Hemodialysis (USA)

NCT02358967

End Stage Renal Disease Chronic Kidney Disease

COMPLETED NA

Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

NCT00908297

Cardiovascular Disease End Stage Renal Disease Atherosclerosis +1 more

COMPLETED NA

Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients

NCT06286735

Chronic Kidney Diseases

NOT_YET_RECRUITING NA

The Effect of CoQ10 Administration on Hemodialysis Patients

NCT00307996

Chronic Renal Failure Hemodialysis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases Hemodialysis Microbiota Oxidative Stress Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Effects of supplementation with tocotrienol on chronic kidney disease patients

Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months.

Group Type EXPERIMENTAL

Tocotrienol rich fraction

Intervention Type DIETARY_SUPPLEMENT

Supplementation with a Vitamin E compound.

Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients

Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tocotrienol rich fraction

Supplementation with a Vitamin E compound.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic kidney disease
* Aged from 18 to 60 years
* Must be able to swallow capsules

Exclusion Criteria

* Pregnant patients
* Smokers
* Using antibiotics in the last 3 months
* Using antioxidant supplements in the last 3 months
* Usual intake Autoimmune
* Hemodialysis started less than 6 months for hemodialysis patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No