Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children

July 16, 2014 updated by: Azadeh Eshraghi, Shahid Beheshti University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Hamedan, Iran, Islamic Republic of
        • Recruiting
        • Hamedan University of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Azadeh Eshraghi
        • Principal Investigator:
          • Golnaz Vaseghi
        • Principal Investigator:
          • Maryam Mehrpooya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • neurogenic bladder,
  • systemic hypertension,
  • obstructive uropathy,
  • High grade vesicoureteral

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omega-3
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
Drug: Omega-3
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
No Intervention: Control
control group received just standard regimens without omega-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of 99mTc-dimercaptosuccinic acid (DMSA) scan
Time Frame: Baseline and 4 months
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary biomarker of acute kidney injury (NGAL)
Time Frame: 3th day
3th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Investigators

  • Principal Investigator: Alaleh Gheisari, Pediatric Nephrologist,Isfahan University, Isfahan, Iran
  • Principal Investigator: Maryam Mehrpooya, Ph.D, Hamedan University of Medical Sciences
  • Principal Investigator: Elham Jafari, Ph.D, Isfahan University, Isfahan, Iran
  • Principal Investigator: Azadeh Eshraghi, Ph.D, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Golnaz Vaseghi, Ph.D, Physiology Research Center,Isfahan University of Medical Sciences
  • Principal Investigator: Iraj Sedighi, Pediatric infectious disease,Hamedan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

July 13, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shahid Behesti University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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