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

NCT02192580 | Unknown Phase 3 DMC

• 1 other identifier: Shahid Behesti University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pyelonephritis(APN)

Outcome Measures

Primary Outcomes (1)

• Change of 99mTc-dimercaptosuccinic acid (DMSA) scan

  Baseline and 4 months

Secondary Outcomes (1)

• Urinary biomarker of acute kidney injury (NGAL)

  3th day

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

control group received just standard regimens without omega-3

Interventions

Omega-3 DRUG

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

Omega-3

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Hamedan University of Medical Sciences

Hamadan, Iran

RECRUITING

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azadeh Eshraghi, Ph.D

CONTACT

aepharm@gmail.com

Golnaz Vaseghi, Ph.D

CONTACT

golnazvaseghi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

IR (1)