The purpose of this clinical trial study that will be done in neonatal ward Shahid Madani hospital in Khorramabad city is to evaluate the effect of oral zinc sulfate on bilirubin level in healthy term neonates. The main inclusion criteria includes: Term newborns; Birth weight more than than 2500 grams; Without any signs of abnormalities and diseases (infectious, metabolic, hemolytic, glucose-six-phosphate dehydrogenase deficiency, blood group incompatibility and positive coombs test). The main exclusion criterion is the need for exchange transfusion. Newborns are assigned into two different groups with using blocked randomization: Control and treatment. The newborns in Control group will receive only continuous phototherapy; the treatment group in addition to continuous phototherapy will receive 5 mg of oral zinc sulfate twice a day. In both groups total bilirubin levels of serum will be measured at 24, 48, 72, and 96 hours after intervention. The main outcome of this study is to see the effect of oral zinc sulfate on the total bilirubin levels of serum. The duration of phototherapy will be recorded also in two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312067697N3
Registration date:2014-02-16, 1392/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-16, 1392/11/27
Registrant information
Name
Shourangiz Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1330 5313
Email address
shorangiz.beiranvand@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Lorestan University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral zinc sulfate on the reduction of bilirubin level term jaundiced neonates during phototherapy.
Public title
The effect of oral zinc sulfate on the reduction of bilirubin level term jaundiced neonates during phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Term neonates; Gestational age of 37- 41 weeks; Birth weight more than 2500 grams; The minimum and maximum age of the infants between 3 - 28 days; Total bilirubin levels of Serum between 14 - 19 mg/dl; without any sign of abnormalities and diseases (infectious, metabolic, hemolytic, glucose-six-phosphate dehydrogenase deficiency, blood group incompatibility and positive coombs test). Exclusion criteria: The need for exchange transfusion and intensive care for more than 24 hours.
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:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by using blocked randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Department of Research and Technology, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
Postal code
381351698
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
96196/200
Health conditions studied
1
Description of health condition studied
Neonatal Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice unspecified
Primary outcomes
1
Description
Total bilirubin levels of serum
Timepoint
Before intervention, 24, 48, 72 and 96 hours after intervention
Method of measurement
Measurement of serum total bilirubin (diazo method)
Secondary outcomes
1
Description
Duration of phototherapy
Timepoint
Daily
Method of measurement
Duration of phototherapy (days)
Intervention groups
1
Description
Intervention group: Newborns during continuous phototherapy will receive 5 mg of oral zinc sulfate twice a day.
Category
Treatment - Drugs
2
Description
Group control: Newborns only will receive continuous phototherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Shourangiz Beiranvand
Street address
Nursing Department, Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Kaedi
Street address
Vice Chancellor for Research, Lorestan University of Medical Sciences, Kamalvand
City
Khorramabad
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 Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Shourangiz Beiranvand
Position
Master of nursing, Faculty member of Lorestan University of Medical Sciences
Other areas of specialty/work
Street address
Nursing Department, Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Kamalvand