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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192580
Recruitment Status : Unknown
Verified July 2014 by Azadeh Eshraghi, Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Azadeh Eshraghi, Shahid Beheshti University

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.


Condition or disease Intervention/treatment Phase
Acute Pyelonephritis(APN) Drug: Omega-3 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change of 99mTc-dimercaptosuccinic acid (DMSA) scan [ Time Frame: Baseline and 4 months ]

Secondary Outcome Measures :
  1. Urinary biomarker of acute kidney injury (NGAL) [ Time Frame: 3th day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192580


Contacts
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Contact: Azadeh Eshraghi, Ph.D aepharm@gmail.com
Contact: Golnaz Vaseghi, Ph.D golnazvaseghi@yahoo.com

Locations
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Iran, Islamic Republic of
Hamedan University of Medical Sciences Recruiting
Hamedan, Iran, Islamic Republic of
Contact: Azadeh Eshraghi, Ph.d       aepharm@gmail.com   
Contact: Golnaz Vaseghi, Ph.D       golnazvaseghi@yahoo.com   
Principal Investigator: Azadeh Eshraghi         
Principal Investigator: Golnaz Vaseghi         
Principal Investigator: Maryam Mehrpooya         
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Principal Investigator: Maryam Mehrpooya, Ph.D Hamedan University of Medical Sciences
Principal Investigator: Alaleh Gheisari Pediatric Nephrologist,Isfahan University, Isfahan, Iran
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
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Responsible Party: Azadeh Eshraghi, Clinical Pharmacist, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT02192580    
Other Study ID Numbers: Shahid Behesti University
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis