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

Universidade Federal Fluminense

Status: Completed

Conditions: Chronic Kidney Diseases; Hemodialysis; Peritoneal Dialysis

Treatments: Dietary Supplement: Curcumin supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04413266

Denise Mafra7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Curcumin for CKD

Active Comparator group

Description:

Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks

Treatment:

Dietary Supplement: Curcumin supplementation

Placebo for CKD

Placebo Comparator group

Description:

Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks

Treatment:

Dietary Supplement: Curcumin supplementation