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

• Sponsor: Shahid Beheshti University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02192580
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pyelonephritis(APN)	Drug: Omega-3	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of 99mTc-dimercaptosuccinic acid (DMSA) scan [Baseline and 4 months]

Secondary Outcome Measures

1. Urinary biomarker of acute kidney injury (NGAL) [3th day]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamedan University of Medical Sciences	Hamedan		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azadeh Eshraghi, Clinical Pharmacist, Shahid Beheshti University
• ClinicalTrials.gov Identifier: NCT02192580
• Other Study ID Numbers: Shahid Behesti University
• First Posted: Jul 17, 2014
• Last Update Posted: Jul 17, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Pyelonephritis

Study Results

No Results Posted as of Jul 17, 2014