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

NCT ID: NCT04413266

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2023-10-05

Brief Summary

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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

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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

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Chronic Kidney Diseases Peritoneal Dialysis Hemodialysis

Keywords

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chronic kidney disease peritoneal dialysis curcumin hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Curcumin for CKD

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

Group Type ACTIVE_COMPARATOR

Curcumin supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Placebo for CKD

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

Group Type PLACEBO_COMPARATOR

Curcumin supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Curcumin supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dietary Supplement Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal Fluminense

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denise Mafra, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Federal University Fluminense

Locations

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Denise Mafra

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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Reis DCMV, Alvarenga L, Cardozo LFMF, Baptista BG, Fanton S, Paiva BR, Ribeiro-Alves M, Fortunato RS, Vasconcelos AL, Nakao LS, Sanz CL, Berretta AA, Leite M Jr, Mafra D. Can curcumin supplementation break the vicious cycle of inflammation, oxidative stress, and uremia in patients undergoing peritoneal dialysis? Clin Nutr ESPEN. 2024 Feb;59:96-106. doi: 10.1016/j.clnesp.2023.11.015. Epub 2023 Nov 28.

Reference Type DERIVED
PMID: 38220413 (View on PubMed)

Other Identifiers

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Denise Mafra7

Identifier Type: -

Identifier Source: org_study_id