Skip to main content
OpenTrials
Completed

NCT Number: NCT04413266

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin Supplementation

Dietary Supplement

The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks

Other names: Dietary Supplement, Placebo

Primary outcomes

  1. Antioxidants and anti-inflammatory biomarkers

    Time frame: 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)

  2. Inflammatory biomarkers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2020
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.