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

Sponsor
Universidade Federal Fluminense (Other)
Overall Status
Recruiting
CT.gov ID
NCT04413266
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
19.7
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Curcumin supplementation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis
Actual Study Start Date :
Oct 10, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Curcumin for CKD

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

Dietary Supplement: Curcumin supplementation
The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
Other Names:
  • Dietary Supplement
  • Placebo

    		•
    Placebo Comparator: Placebo for CKD

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

    Dietary Supplement: Curcumin supplementation
    The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
    Other Names:
  • Dietary Supplement
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Antioxidants and anti-inflammatory biomarkers [4 weeks]

      Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathione peroxidase (GPx), heme oxygenase-1 (HO-1)

    2. Inflammatory biomarkers [4 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Denise Mafra Rio de Janeiro RJ Brazil 22260050

    Sponsors and Collaborators

    • Universidade Federal Fluminense

    Investigators

    • Principal Investigator: Denise Mafra, Ph.D, Federal University Fluminense

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universidade Federal Fluminense
    ClinicalTrials.gov Identifier:
    NCT04413266
    Other Study ID Numbers:
    • Denise Mafra7
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universidade Federal Fluminense
    chronic kidney disease
    peritoneal dialysis
    curcumin
    hemodialysis
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Curcumin

    Study Results

    No Results Posted as of Jan 5, 2022