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

Primary Purpose

Acute Pyelonephritis(APN)

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Omega-3
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pyelonephritis(APN)

Eligibility Criteria

1 Month - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamedan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Omega-3

Control

Arm 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

control group received just standard regimens without omega-3

Outcomes

Primary Outcome Measures

Change of 99mTc-dimercaptosuccinic acid (DMSA) scan

Secondary Outcome Measures

Urinary biomarker of acute kidney injury (NGAL)

Full Information

First Posted
July 13, 2014
Last Updated
July 16, 2014
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT02192580
Brief Title
Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pyelonephritis(APN)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Active Comparator
Arm 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 Title
Control
Arm Type
No Intervention
Arm Description
control group received just standard regimens without omega-3
Intervention Type
Drug
Intervention Name(s)
Omega-3
Intervention 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
Primary Outcome Measure Information:
Title
Change of 99mTc-dimercaptosuccinic acid (DMSA) scan
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Urinary biomarker of acute kidney injury (NGAL)
Time Frame
3th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azadeh Eshraghi, Ph.D
Email
aepharm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Golnaz Vaseghi, Ph.D
Email
golnazvaseghi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Mehrpooya, Ph.D
Organizational Affiliation
Hamedan University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaleh Gheisari
Organizational Affiliation
Pediatric Nephrologist,Isfahan University, Isfahan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elham Jafari, Ph.D
Organizational Affiliation
Isfahan University, Isfahan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi, Ph.D
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi, Ph.D
Organizational Affiliation
Physiology Research Center,Isfahan University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iraj Sedighi
Organizational Affiliation
Pediatric infectious disease,Hamedan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamedan University of Medical Sciences
City
Hamedan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi, Ph.d
Email
aepharm@gmail.com
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi, Ph.D
Email
golnazvaseghi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi
First Name & Middle Initial & Last Name & Degree
Maryam Mehrpooya

12. IPD Sharing Statement

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

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