Clinical Trials Directory

Trials / Completed

CompletedNCT04413266

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Universidade Federal Fluminense · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCurcumin supplementationThe patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks

Timeline

Start date
2020-10-10
Primary completion
2023-10-05
Completion
2023-10-05
First posted
2020-06-02
Last updated
2023-12-14

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04413266. Inclusion in this directory is not an endorsement.