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

Not Applicable

Completed

• Conditions: Peritoneal Dialysis; Hemodialysis; Chronic Kidney Diseases
• Interventions: Dietary Supplement: Curcumin supplementation

• Registration Number: NCT04413266
• Lead Sponsor: Universidade Federal Fluminense

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2020-10-10
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo for CKD	Curcumin supplementation	Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
Curcumin for CKD	Curcumin supplementation	Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks

Primary Outcome Measures

Name	Time	Method
Antioxidants and anti-inflammatory biomarkers	4 weeks	Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathione peroxidase (GPx), heme oxygenase-1 (HO-1)
Inflammatory biomarkers	4 weeks	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.

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil