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Completed

NCT Number: NCT04900532

Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocotrienol rich fraction

Dietary Supplement

Supplementation with a Vitamin E compound.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in antioxidants and anti-inflammatory biomarkers

    Time frame: 4 weeks

    Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1).

    glutathione peroxidase (GPx), heme oxygenase-1 (HO-1) and microbiota composition from patients feces DNA uremic toxins

Secondary outcomes

  1. Change in inflammatory biomarkers

    Time frame: 4 weeks

    Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha).

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Collaborators

  • Wayne State University

Registry information

Official study title

Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2023
First posted
May 25, 2021
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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