Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Conditions
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Chronic Kidney Diseases, Peritoneal Dialysis, Hemodialysis

Intervention / Treatment
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* Dietary Supplement: Curcumin supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Chronic Kidney Disease Peritoneal dialysis patients for more than 6 months Aged from 18 to 60 years Must be able to swallow tablets Exclusion Criteria: Patients pregnant Smokers Using antibiotics in the last 3 months Using antioxidant supplements in the last 3 months Usual intake of turmeric Usual intake Autoimmune Clinical diagnosis of infectious diseases Clinical diagnosis of Cancer Clinical diagnosis of AIDS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcumin for CKD<br>Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks | Dietary Supplement: Curcumin supplementation<br>* The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks<br>* Other names: Placebo;|
| Placebo Comparator: Placebo for CKD<br>Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks | Dietary Supplement: Curcumin supplementation<br>* The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, peritoneal dialysis, curcumin, hemodialysis