Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Universidade Federal Fluminense

Status: Completed

Conditions: Chronic Kidney Diseases; Inflammation; Hemodialysis; Oxidative Stress; Microbiota

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Tocotrienol rich fraction

Study type: Interventional

Funder types: Other

Identifiers

NCT04900532

Denise Mafra

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Effects of supplementation with tocotrienol on chronic kidney disease patients

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tocotrienol rich fraction

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

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo