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
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
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
NCT ID
NCT04413266
First Posted
May 28, 2020
Last Updated
September 15, 2022
Sponsor
Universidade Federal Fluminense
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
Learn more about this trial
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
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