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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413266
• Other study ID #: Denise Mafra7
• Status: Completed
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: October 5, 2023

Study information

• Verified date: December 2023
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hemodialysis
• Kidney Diseases
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Curcumin supplementation
The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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