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Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Primary Purpose

Chronic Kidney Diseases, Hemodialysis, Microbiota

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tocotrienol rich fraction
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denise Mafra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Effects of supplementation with tocotrienol on chronic kidney disease patients

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

Antioxidants and anti-inflammatory biomarkers
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 Outcome Measures

Inflammatory biomarkers
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).

Full Information

First Posted
December 4, 2020
Last Updated
August 11, 2021
Sponsor
Universidade Federal Fluminense
Collaborators
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT04900532
Brief Title
Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients
Official Title
Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense
Collaborators
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hemodialysis, Microbiota, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effects of supplementation with tocotrienol on chronic kidney disease patients
Arm Type
Experimental
Arm Description
Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months.
Arm Title
Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients
Arm Type
Placebo Comparator
Arm Description
Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tocotrienol rich fraction
Intervention Description
Supplementation with a Vitamin E compound.
Primary Outcome Measure Information:
Title
Antioxidants and anti-inflammatory biomarkers
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Inflammatory biomarkers
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil

12. IPD Sharing Statement

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Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

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