Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
October 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2023
CompletedDecember 14, 2023
December 1, 2023
3 years
May 28, 2020
December 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Curcumin for CKD
ACTIVE COMPARATORAdministration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
Placebo for CKD
PLACEBO COMPARATORAdministration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
Interventions
The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050, Brazil
Related Publications (1)
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.
PMID: 38220413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Mafra, Ph.D
Federal University Fluminense
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
October 10, 2020
Primary Completion
October 5, 2023
Study Completion
October 5, 2023
Last Updated
December 14, 2023
Record last verified: 2023-12