An interventional study of Curcumin supplementation in Chronic Kidney Diseases, Peritoneal Dialysis and Hemodialysis, sponsored by Universidade Federal Fluminense. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Universidade Federal Fluminense · Not applicable, Interventional, and Health services research
The objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.
Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been suggested as a nutritional strategy to reduce oxidative stress and inflammation present in several chronic diseases. Although it is a promising therapy, there are no studies evaluating the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis (PD). The aim of this study is to evaluate the effect of curcumin supplementation on inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a longitudinal randomized clinical double-blind crossover study, with a washout period and placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo. After the 12-week supplementation period, a washout (12 weeks) will be performed for subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory parameters, as well as food intake and nutritional status.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Universidade Federal Fluminense is the lead sponsor of 72 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
Dietary Supplement: Curcumin supplementation
Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
Dietary Supplement: Curcumin supplementation
The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
Also known as: Dietary Supplement, Placebo
Antioxidants and anti-inflammatory biomarkers
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathione peroxidase (GPx), heme oxygenase-1 (HO-1)
Time frame: 4 weeks
Inflammatory biomarkers
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappaB, interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), PCR, IL-18, TBARS, Inflammasome.
Time frame: 4 weeks
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Universidade Federal Fluminense