Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 26, 2024
February 1, 2024
3 months
December 4, 2020
February 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 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
4 weeks
Secondary Outcomes (1)
Change in inflammatory biomarkers
4 weeks
Study Arms (2)
Effects of supplementation with tocotrienol on chronic kidney disease patients
EXPERIMENTALAdministration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months.
Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients
PLACEBO COMPARATORAdministration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.
Interventions
Supplementation with a Vitamin E compound.
Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.
Eligibility Criteria
You may qualify if:
- Chronic kidney disease
- Aged from 18 to 60 years
- Must be able to swallow capsules
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal Fluminenselead
- Wayne State Universitycollaborator
Study Sites (1)
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050, Brazil
Related Publications (1)
Trugilho L, Alvarenga L, Cardozo L, Paiva B, Brito J, Barboza I, Almeida J, Dos Anjos J, Khosla P, Ribeiro-Alves M, Mafra D. Effects of Tocotrienol on Cardiovascular Risk Markers in Patients With Chronic Kidney Disease: A Randomized Controlled Trial. J Nutr Metab. 2025 Jan 13;2025:8482883. doi: 10.1155/jnme/8482883. eCollection 2025.
PMID: 39840146DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2020
First Posted
May 25, 2021
Study Start
May 1, 2019
Primary Completion
August 1, 2019
Study Completion
December 31, 2023
Last Updated
February 26, 2024
Record last verified: 2024-02