<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413266</url>
  </required_header>
  <id_info>
    <org_study_id>Denise Mafra7</org_study_id>
    <nct_id>NCT04413266</nct_id>
  </id_info>
  <brief_title>Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis</brief_title>
  <official_title>Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal Fluminense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal Fluminense</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess whether supplementation with curcumin could modulate&#xD;
      the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress,&#xD;
      uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal&#xD;
      dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma&#xD;
      (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been&#xD;
      suggested as a nutritional strategy to reduce oxidative stress and inflammation present in&#xD;
      several chronic diseases. Although it is a promising therapy, there are no studies evaluating&#xD;
      the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis&#xD;
      (PD). The aim of this study is to evaluate the effect of curcumin supplementation on&#xD;
      inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a&#xD;
      longitudinal randomized clinical double-blind crossover study, with a washout period and&#xD;
      placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo.&#xD;
      After the 12-week supplementation period, a washout (12 weeks) will be performed for&#xD;
      subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood&#xD;
      and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB),&#xD;
      antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time&#xD;
      Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine&#xD;
      levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory&#xD;
      parameters, as well as food intake and nutritional status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 10, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antioxidants and anti-inflammatory biomarkers</measure>
    <time_frame>4 weeks</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory biomarkers</measure>
    <time_frame>4 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Peritoneal Dialysis</condition>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Curcumin for CKD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for CKD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Curcumin supplementation</intervention_name>
    <description>The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks</description>
    <arm_group_label>Curcumin for CKD</arm_group_label>
    <arm_group_label>Placebo for CKD</arm_group_label>
    <other_name>Dietary Supplement</other_name>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Chronic Kidney Disease&#xD;
&#xD;
          -  Peritoneal dialysis patients for more than 6 months&#xD;
&#xD;
          -  Aged from 18 to 60 years&#xD;
&#xD;
          -  Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients pregnant&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Using antibiotics in the last 3 months&#xD;
&#xD;
          -  Using antioxidant supplements in the last 3 months&#xD;
&#xD;
          -  Usual intake of turmeric&#xD;
&#xD;
          -  Usual intake Autoimmune&#xD;
&#xD;
          -  Clinical diagnosis of infectious diseases&#xD;
&#xD;
          -  Clinical diagnosis of Cancer&#xD;
&#xD;
          -  Clinical diagnosis of AIDS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denise Mafra, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University Fluminense</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denise Mafra, Ph.D</last_name>
    <phone>5521985683003</phone>
    <email>dmafra30@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Denise Mafra, Ph.D</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Denise Mafra</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>22260050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise Mafra, phd</last_name>
      <phone>21985683003</phone>
      <email>dmafra30@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 15, 2022</last_update_submitted>
  <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic kidney disease</keyword>
  <keyword>peritoneal dialysis</keyword>
  <keyword>curcumin</keyword>
  <keyword>hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413266
org study id: Denise Mafra7
nct id: NCT04413266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Antioxidants and anti-inflammatory biomarkers
time frame: 4 weeks
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)
measure: Inflammatory biomarkers
time frame: 4 weeks
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.
arm group label: Curcumin for CKD
arm group type: Active Comparator
description: Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
arm group label: Placebo for CKD
arm group type: Placebo Comparator
description: Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
intervention type: Dietary Supplement
intervention name: Curcumin supplementation
description: The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
arm group label: Curcumin for CKD
arm group label: Placebo for CKD
other name: Dietary Supplement
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Denise Mafra, Ph.D
role: Principal Investigator
affiliation: Federal University Fluminense
last name: Denise Mafra, Ph.D
phone: 5521985683003
email: dmafra30@gmail.com
last name: Denise Mafra, Ph.D
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Curcumin