<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/NCT02192580</url>
  </required_header>
  <id_info>
    <org_study_id>Shahid Behesti University</org_study_id>
    <nct_id>NCT02192580</nct_id>
  </id_info>
  <brief_title>Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary tract infections (UTI) are a common and important clinical problem in childhood.Upper&#xD;
      urinary tract infections (ie, acute pyelonephritis) may lead to renal scarring, hypertension,&#xD;
      and end-stage renal disease.Pathogenesis of acute pyelonephritis (APN) is associated with&#xD;
      urinary tract anatomy and function, bacterial virulence factors, the host innate immune&#xD;
      system and production of free radicals. Oxygen-free radicals and oxidative stress play a role&#xD;
      in renal scar formation after an APN. Oxygen-free radical scavengers and antioxidants can&#xD;
      reduce tissue damage and renal scaring during acute pyelonephritis.we want to publish a study&#xD;
      that indicates that antioxidant therapy with omega-3 given to children with pyelonephritis&#xD;
      may indeed lower the risk for renal scarring.&#xD;
&#xD;
      Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is&#xD;
      a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to&#xD;
      antibiotic on preventing renal scaring after acute pyelonephritis in children. This&#xD;
      randomized clinical trial on 60 patients in 2 groups (intervention &amp; control) is&#xD;
      conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings,&#xD;
      and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute&#xD;
      pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder,&#xD;
      systemic hypertension, obstructive uropathy and high grade vesicouretera are&#xD;
      excluded.Patients in Intervention group are administered omega-3 based on body weight in&#xD;
      divided doses in addition to antibiotic regimens and patients in control group received&#xD;
      antibiotic regimens without omega-3. Primary outcome is the development of renal scar by&#xD;
      doing DMSA renal scan on the 7th day of admission and four to six months after the&#xD;
      intervention and compared between groups.Also,measurement of urinary biomarker of acute&#xD;
      kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of&#xD;
      subsequent scarring in both groups will be done . Secondary outcome is the incidence and&#xD;
      severity of renal scarring after pyelonephritis and response to treatment between two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of 99mTc-dimercaptosuccinic acid (DMSA) scan</measure>
    <time_frame>Baseline and 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary biomarker of acute kidney injury (NGAL)</measure>
    <time_frame>3th day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Pyelonephritis(APN)</condition>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>omega-3 (DHA+EPA) in divided 3 times/day in addition to standard regimens: Children less than 18 kg:26 mg/kg EPA and 11 mg/kg DHA Children 18-24 kg:504 mg EPA and 216 mg DHA Children 25-32 kg:672 mg EPA and 288 mg DHA Children 33-41 kg:840 mg EPA and 360 mg DHA Children 5-15 years:1000 mg EPA and 878 mg DHA omega-3 in divided 3 times/day in addition to standard regimens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group received just standard regimens without omega-3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega-3</intervention_name>
    <description>Children less than 18 kg:26 mg/kg EPA and 11 mg/kg DHA Children 18-24 kg:504 mg EPA and 216 mg DHA Children 25-32 kg:672 mg EPA and 288 mg DHA Children 33-41 kg:840 mg EPA and 360 mg DHA Children 5-15 years:1000 mg EPA and 878 mg DHA omega-3 in divided 3 times/day in addition to standard regimens</description>
    <arm_group_label>Omega-3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 1 month to 10 years with positive urine culture, clinical findings, and&#xD;
             99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute&#xD;
             pyelonephritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurogenic bladder,&#xD;
&#xD;
          -  systemic hypertension,&#xD;
&#xD;
          -  obstructive uropathy,&#xD;
&#xD;
          -  High grade vesicoureteral&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maryam Mehrpooya, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamedan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alaleh Gheisari</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatric Nephrologist,Isfahan University, Isfahan, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elham Jafari, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isfahan University, Isfahan, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azadeh Eshraghi, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Golnaz Vaseghi, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physiology Research Center,Isfahan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iraj Sedighi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatric infectious disease,Hamedan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Azadeh Eshraghi, Ph.D</last_name>
    <email>aepharm@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Golnaz Vaseghi, Ph.D</last_name>
    <email>golnazvaseghi@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hamedan University of Medical Sciences</name>
      <address>
        <city>Hamedan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Azadeh Eshraghi, Ph.d</last_name>
      <email>aepharm@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Golnaz Vaseghi, Ph.D</last_name>
      <email>golnazvaseghi@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Azadeh Eshraghi</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Golnaz Vaseghi</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maryam Mehrpooya</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>Azadeh Eshraghi</investigator_full_name>
    <investigator_title>Clinical Pharmacist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyelonephritis</mesh_term>
  </condition_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/NCT02192580
org study id: Shahid Behesti University
nct id: NCT02192580
lead sponsor: 
has dmc: Yes
Urinary tract infections (UTI) are a common and important clinical problem in childhood.Upper
      urinary tract infections (ie, acute pyelonephritis) may lead to renal scarring, hypertension,
      and end-stage renal disease.Pathogenesis of acute pyelonephritis (APN) is associated with
      urinary tract anatomy and function, bacterial virulence factors, the host innate immune
      system and production of free radicals. Oxygen-free radicals and oxidative stress play a role
      in renal scar formation after an APN. Oxygen-free radical scavengers and antioxidants can
      reduce tissue damage and renal scaring during acute pyelonephritis.we want to publish a study
      that indicates that antioxidant therapy with omega-3 given to children with pyelonephritis
      may indeed lower the risk for renal scarring.

      Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is
      a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to
      antibiotic on preventing renal scaring after acute pyelonephritis in children. This
      randomized clinical trial on 60 patients in 2 groups (intervention & control) is
      conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings,
      and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute
      pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder,
      systemic hypertension, obstructive uropathy and high grade vesicouretera are
      excluded.Patients in Intervention group are administered omega-3 based on body weight in
      divided doses in addition to antibiotic regimens and patients in control group received
      antibiotic regimens without omega-3. Primary outcome is the development of renal scar by
      doing DMSA renal scan on the 7th day of admission and four to six months after the
      intervention and compared between groups.Also,measurement of urinary biomarker of acute
      kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of
      subsequent scarring in both groups will be done . Secondary outcome is the incidence and
      severity of renal scarring after pyelonephritis and response to treatment between two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change of 99mTc-dimercaptosuccinic acid (DMSA) scan
time frame: Baseline and 4 months
measure: Urinary biomarker of acute kidney injury (NGAL)
time frame: 3th day
arm group label: Omega-3
arm group type: Active Comparator
description: omega-3 (DHA+EPA) in divided 3 times/day in addition to standard regimens: Children less than 18 kg:26 mg/kg EPA and 11 mg/kg DHA Children 18-24 kg:504 mg EPA and 216 mg DHA Children 25-32 kg:672 mg EPA and 288 mg DHA Children 33-41 kg:840 mg EPA and 360 mg DHA Children 5-15 years:1000 mg EPA and 878 mg DHA omega-3 in divided 3 times/day in addition to standard regimens
arm group label: Control
arm group type: No Intervention
description: control group received just standard regimens without omega-3
intervention type: Drug
intervention name: Omega-3
description: Children less than 18 kg:26 mg/kg EPA and 11 mg/kg DHA Children 18-24 kg:504 mg EPA and 216 mg DHA Children 25-32 kg:672 mg EPA and 288 mg DHA Children 33-41 kg:840 mg EPA and 360 mg DHA Children 5-15 years:1000 mg EPA and 878 mg DHA omega-3 in divided 3 times/day in addition to standard regimens
arm group label: Omega-3
criteria: 
gender: All
minimum age: 1 Month
maximum age: 10 Years
healthy volunteers: No
last name: Maryam Mehrpooya, Ph.D
role: Principal Investigator
affiliation: Hamedan University of Medical Sciences
last name: Alaleh Gheisari
role: Principal Investigator
affiliation: Pediatric Nephrologist,Isfahan University, Isfahan, Iran
last name: Elham Jafari, Ph.D
role: Principal Investigator
affiliation: Isfahan University, Isfahan, Iran
last name: Azadeh Eshraghi, Ph.D
role: Principal Investigator
affiliation: Shahid Beheshti University of Medical Sciences
last name: Golnaz Vaseghi, Ph.D
role: Principal Investigator
affiliation: Physiology Research Center,Isfahan University of Medical Sciences
last name: Iraj Sedighi
role: Principal Investigator
affiliation: Pediatric infectious disease,Hamedan University of Medical Sciences
last name: Azadeh Eshraghi, Ph.D
email: aepharm@gmail.com
last name: Golnaz Vaseghi, Ph.D
email: golnazvaseghi@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: Azadeh Eshraghi
investigator title: Clinical Pharmacist
mesh term: Pyelonephritis