L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis

This study is currently recruiting participants.
Verified December 2013 by Shahid Beheshti University
Sponsor:
Information provided by (Responsible Party):
Azadeh Eshraghi, Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT02007889
First received: September 21, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in treatment of acute infection.The pathogenesis of APN is related to bacterial virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress response may provide a therapeutic effect in preventing renal pathologies. Animal model show that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be prevented much more effectively by carnitine in addition to conventional antibiotic treatment in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute pyelonephritis in children. Simple non- blind randomized clinical trial on 78 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 were excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy. Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA renal scan on the 7th day of admission and six months after the intervention and compared between groups and secondary outcome is the incidence and severity of pyelonephritis and response to treatment.


Condition Intervention Phase
Acute Pyelonephritis(APN)
Drug: L-carnitine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effect of L-carnitine on the Prevention of Renal Scarring in Children With Acute Pyelonephritis

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • Development of renal scar by doing DMSA renal scan [ Time Frame: Seven and six months after the intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of pyelonephritis and response to treatment. [ Time Frame: Six month after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-carnitine
50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
Drug: L-carnitine
50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
No Intervention: Control
control group received just antibiotic regimens without L-carnitine

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007889

Contacts
Contact: Azadeh Eshraghi, Ph.D 009809133152584 aepharm@gmail.com

Locations
Iran, Islamic Republic of
Isfahan University of Medical Sciences,Alzahra Hospital Recruiting
Isfahan, Iran, Islamic Republic of, 0098
Contact: Azadeh Eshraghi, Ph.D    009809133152584    aepharm@gmail.com   
Sponsors and Collaborators
Shahid Beheshti University
Investigators
Principal Investigator: Golnaz Vaseghi, Ph.D pharmacology Physiology Research Center
Principal Investigator: Alaleh Gheisari Pediatric Nephrologist,Isfahan University, Isfahan, Iran
Principal Investigator: Nahid Aslani, Resident of pediatrics Isfahan University of Medical Sciences
Principal Investigator: Azadeh Eshraghi, Clinical Pharmacist Shahid Beheshti University of Medical Sciences
  More Information

No publications provided

Responsible Party: Azadeh Eshraghi, Clinical Pharmacist, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT02007889     History of Changes
Other Study ID Numbers: ShahidBU
Study First Received: September 21, 2013
Last Updated: December 5, 2013
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Pyelonephritis
Cicatrix
Fibrosis
Pathologic Processes
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014