The aim of this study was to determine the therapeutic effect of zinc sulfate in healthy term jaundiced neonates. Healthy jaundiced neonates, more than 38 th weeks gestational age, birth weight more than 2500 gr and indirect bilirubin in therapeutic level will elect. Exclusion criteria include: hemolytic disease, massive hemorrhage, G6PD deficiency, sepsis, respiratory distress with ventilator support, and congenital anomaly. Thirty five neonates (case group) will treat with a single oral dose of zinc sulfate as 2 cc daily plus phototherapy and another 35 neonates (control group)will receive only phototherapy. Zinc sulfate syrup includes 5 mgr in 1 ml, therefore the dose is 10mg daily. The plasma total bilirubin levels of 24th, 48th, 72th and 96th hours after treatment were measured .Duration of phototherapy also was recorded. Physical exam will control for drug side effect.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306031162N19
Registration date:2013-06-17, 1392/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2013-11-16, 1392/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral zinc sulfate in reduction of jaundice in term neonates
Public title
Effect of oral zinc sulfate in reduction of jaundice in term neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Healthy jaundiced neonates, more than 38 th weeks gestational age, birth weight more than 2500 gr and indirect bilirubin in therapeutic level
Exclusion: hemolytic disease, massive hemorrhage, G6PD deficiency, sepsis, respiratory distress with ventilator support, and congenital anomaly
Age
From 3 years old to 28 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chanceler of mashhad university of medical science
Street address
ghoreshi bulding-daneshgah street
City
mashhad
Postal code
91379-13131
Approval date
2013-05-25, 1392/03/04
Ethics committee reference number
910894
Health conditions studied
1
Description of health condition studied
jaundice term newborns
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
decreasing serum bilirubine
Timepoint
befor intervention,24 , 48, 72 and 96 after intervention
Method of measurement
blood serum bilirobin(diazo method)
Secondary outcomes
1
Description
decreasing of jaundice in neonate
Timepoint
daily
Method of measurement
date of dissconection of potothorapy
2
Description
date of disconnection of phototrapy
Timepoint
daily
Method of measurement
decreasing of serum bilirobin below phototrapy level
Intervention groups
1
Description
zinc sulfate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Emamreza hospital and NICU Ghaem hospital
Full name of responsible person
dr.Ashraf mohammadzadeh
Street address
NRC-NICU-Emamreza hospital
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
dr Mohsen Tafaghodi
Street address
ghoreshi bulding-daneshgah street
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical science
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
Neonatal Research Center
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
mashhad
Postal code
Phone
+98 51 1852 1121
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
mashhad
Postal code
Phone
+98 51 1852 1121
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
dr Ashraf Mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
mashhad
Postal code
Phone
+98 51185
Fax
Email
mohamadzadeha@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)