Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children
NCT ID: NCT02192580
Last Updated: 2014-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2014-07-31
2015-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
Control
control group received just standard regimens without omega-3
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* systemic hypertension,
* obstructive uropathy,
* High grade vesicoureteral
1 Month
10 Years
ALL
No
Sponsors
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Shahid Beheshti University
OTHER
Responsible Party
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Azadeh Eshraghi
Clinical Pharmacist
Principal Investigators
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Maryam Mehrpooya, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hamedan University of Medical Sciences
Alaleh Gheisari
Role: PRINCIPAL_INVESTIGATOR
Pediatric Nephrologist,Isfahan University, Isfahan, Iran
Elham Jafari, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Isfahan University, Isfahan, Iran
Azadeh Eshraghi, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Golnaz Vaseghi, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Physiology Research Center,Isfahan University of Medical Sciences
Iraj Sedighi
Role: PRINCIPAL_INVESTIGATOR
Pediatric infectious disease,Hamedan University of Medical Sciences
Locations
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Hamedan University of Medical Sciences
Hamadan, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Shahid Behesti University
Identifier Type: -
Identifier Source: org_study_id
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