We evaluated the effect of Vitamin A (anti-inflammatory) and Vitamin E (antioxidant) in addition to antibiotic in children who suffered of acute pyelonephritis on prevention of renal scarring. In this study, 60 children with acute pyelonephritis admitted in Ali-Asghar children hospital were enrolled into a clinical trial. The patients were assigned into one of the following three groups. The control groups received antibiotic as Keflin, 100mg/kg/day, every 6 hours and Amikacin, 15mg/kg/day, every 8 hours. In the intervention groups, vitamin A (1500 Unit/kg/day, for 10 days) or vitamin E (15-25 IU/day, for 10 days) was added to the antibiotics. The development of renal scar was evaluated by doing DMSA renal scan on the second day of admission and six months after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103256102N1
Registration date:2011-04-29, 1390/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-29, 1390/02/09
Registrant information
Name
Nakysa Hooman
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6211
Email address
nhooman@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2004-09-01, 1383/06/11
Expected recruitment end date
2006-10-31, 1385/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin E and Vitamin A on the prevention of renal scarring according to DMSA findings in children with acute pyelonephritis
Public title
Vitamins in Prevention of Renal Scars in Pyelonephritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: positive urine culture, clinical findings, and 99mTC-DMSA criteria of APN
Exclusion criteria: presence of neurogenic bladder, systemic hypertension, obstructive uropathy, high grade vesico-ureteral reflux (Grade 4-5)
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
601, 6th floor, Central building of TUMS, Gods St., Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2005-11-21, 1384/08/30
Ethics committee reference number
7951-16,4,83
Health conditions studied
1
Description of health condition studied
Acute Pyelonephritis
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Renal scar
Timepoint
at least 6 month apart
Method of measurement
Criteria of developing scar in 99mTC-DMSA
Secondary outcomes
1
Description
intolerance to vitamins
Timepoint
daily
Method of measurement
daily clinical observation
2
Description
no response to antibiotic thepay
Timepoint
daily
Method of measurement
urine culture at the 3rd day, clinical observation for fever and general condition
Vitamin A group: Keflin or Ampicillin 100mg/kg/day qid and Amikacin 15mg/kg/day, tid for 10 days, as well as vitamin A, 1500 U/kg/day for 10 days
Category
Treatment - Drugs
2
Description
Control group: Keflin or Ampicillin 100mg/kg/day qid as well as Amikacin 15mg/kg/day, tid for 10 days, or appropriate to antibiogram if it is available
Category
Treatment - Drugs
3
Description
Vitamin E group: A group: Keflin or Ampicillin 100mg/kg/day qid and Amikacin 15mg/kg/day, tid for 10 days, as well as vitamin E 15-25U/day, for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali- Asghar Children Hospital
Full name of responsible person
Street address
Vahid dasgerdi st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Dr Seyed Ahmad Rezaii
Street address
601, 6th floor, Central building TUMS, Gods st., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
2198-84.8.30
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behnam Sobooti
Position
Resident of Pediatric
Other areas of specialty/work
Street address
ALi-Asghar Children hospital, Vahid Dasgerdi st., Modares freeway