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| Name | Class |
|---|---|
| Wayne State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effects of supplementation with tocotrienol on chronic kidney disease patients | Experimental | Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months. |
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| Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients | Placebo Comparator | Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol rich fraction | Dietary Supplement | Supplementation with a Vitamin E compound. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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). | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Rio de Janeiro | Rio de Janeiro | 22260050 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39840146 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Dietary Supplement | Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |