Urinary tract infection (UTI) is a common problem in pediatric population that can cause renal scaring, and eventually, chronic kidney failure. Urinary tract infection occurs in 3% to 5% of girls and 1% of boys during childhood. Pyelonephritis is a inflammatory process in kidney that results in persistent injury to kidney. Virulence factors and defense response of host play important role in pyelonephritis and inflammatory response. Omega-3 is a supplement that has anti-inflammatory and antioxidant effect. This double blinded randomized clinical trial (patients and researchers are unaware of when the experimental medicine has been given) on 60 children with acute pyelonephritis were performed.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 vesicoureteral 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 six months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062922965N1
Registration date:2015-09-23, 1394/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-23, 1394/07/01
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 on the prevention of renal scarring according to dimercaptosuccinic acid (DMSA) findings in children with acute pyelonephritis
Public title
Omega-3 in prevention of renal scars in pyelonephritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Children aged between 1 months and 10 years old with a definite diagnosis of acute pyelonephritis based on clinical; laboratory and 99m Tc-DMSA renal scan finding
Exclusion criteria:Children with neurogenic bladder;systemic hypertension; obstructive uropathy; and high grade vesicoureteral (grade4–5)
Age
From 1 month old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Both the subjects participating and the researchers are unaware of when the experimental medication or procedure has been given
Secondary Ids
1
Registry name
clinicaltrails.Gov
Secondary trial Id
NCT02192580
Registration date
2014-07-13, 1393/04/22
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Khajerashid junction, Ayatollah kashani boulevard, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
249
Health conditions studied
1
Description of health condition studied
Pyelonephritis
ICD-10 code
N12
ICD-10 code description
Tubulo-interstitial nephritis, not specified as acute or chronic
Primary outcomes
1
Description
Evaluation of renal Scar
Timepoint
Six months after intervention
Method of measurement
using nuclear scan 99mtc_DMSA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group:approved antibiotic+omega-3 with different doses based on body weight
Category
Prevention
2
Description
Control Group:Only antibiotic therapy without omega-3
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamadan
Postal code
Phone
00
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)