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

Primary Purpose

Chronic Kidney Diseases, Peritoneal Dialysis, Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Curcumin supplementation
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, peritoneal dialysis, curcumin, hemodialysis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Denise MafraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Curcumin for CKD

Placebo for CKD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2020
Last Updated
September 15, 2022
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT04413266
Brief Title
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
Official Title
Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Peritoneal Dialysis, Hemodialysis
Keywords
chronic kidney disease, peritoneal dialysis, curcumin, hemodialysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Curcumin for CKD
Arm Type
Active Comparator
Arm Description
Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
Arm Title
Placebo for CKD
Arm Type
Placebo Comparator
Arm Description
Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin supplementation
Other Intervention Name(s)
Dietary Supplement, Placebo
Intervention Description
The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
Primary Outcome Measure Information:
Title
Antioxidants and anti-inflammatory biomarkers
Description
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathione peroxidase (GPx), heme oxygenase-1 (HO-1)
Time Frame
4 weeks
Title
Inflammatory biomarkers
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Mafra, Ph.D
Phone
5521985683003
Email
dmafra30@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Mafra, Ph.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, Ph.D
Organizational Affiliation
Federal University Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, phd
Phone
21985683003
Email
dmafra30@gmail.com

12. IPD Sharing Statement

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

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