Clinical trial NCT02192580: Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Pyelonephritis(APN)
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change of 99mTc-dimercaptosuccinic acid (DMSA) scan
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Urinary biomarker of acute kidney injury (NGAL)
timeFrame: 3th day
Other outcomes:
Locations:
city: Hamedan
country: Iran, Islamic Republic of
facility: Hamedan University of Medical Sciences
Study officials:
affiliation: Hamedan University of Medical Sciences
name: Maryam Mehrpooya, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Nephrologist,Isfahan University, Isfahan, Iran
name: Alaleh Gheisari
role: PRINCIPAL_INVESTIGATOR
affiliation: Isfahan University, Isfahan, Iran
name: Elham Jafari, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Azadeh Eshraghi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Physiology Research Center,Isfahan University of Medical Sciences
name: Golnaz Vaseghi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric infectious disease,Hamedan University of Medical Sciences
name: Iraj Sedighi
role: PRINCIPAL_INVESTIGATOR
References: