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

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ClinicalTrials.gov Identifier: NCT02007889
Recruitment Status : Unknown
Verified December 2013 by Azadeh Eshraghi, Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Azadeh Eshraghi, Shahid Beheshti University

Tracking Information
First Submitted Date  ICMJE September 21, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
Development of renal scar by doing DMSA renal scan [ Time Frame: Seven and six months after the intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
Severity of pyelonephritis and response to treatment. [ Time Frame: Six month after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis
Official Title  ICMJE The Effect of L-carnitine on the Prevention of Renal Scarring in Children With Acute Pyelonephritis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Acute Pyelonephritis(APN)
Intervention  ICMJE Drug: L-carnitine
50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
Study Arms  ICMJE
  • Active Comparator: L-carnitine
    50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
    Intervention: Drug: L-carnitine
  • No Intervention: Control
    control group received just antibiotic regimens without L-carnitine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02007889
Other Study ID Numbers  ICMJE ShahidBU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Azadeh Eshraghi, Shahid Beheshti University
Study Sponsor  ICMJE Shahid Beheshti University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Shahid Beheshti University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP