Objective: to evaluate the effect of Zinc on Hyperbilirubinemia in newborn babies in Zanjan.
Design: randomized selection, double blind, control group of healthy children admitted to the neonatal ward
Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg / dL; age of 3 to 7 days; using no other drug.
Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion.
Population studied: three to seven days old babies with Hyperbilirubinemia admitted to the neonatal ward of Ayatollah Mousavi Hospital in Zanjan.
Sample size: 112 people
Case study: prescribing Zinc and placebo syrup with a similar amount in three days in the case group and control group and measuring serum bilirubin in every three days.
Time of intervention: no restrictions
Outcome: reducing the serum bilirubin faster than past time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061515835N5
Registration date:2017-10-14, 1396/07/22
Registration timing:prospective
Last update:
Update count:2
Registration date
2017-10-14, 1396/07/22
Registrant information
Name
Parisa Khoshnevisasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 1427 2737
Email address
khoshnevis@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences, vice chancellor for research
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zinc on Hyperbilirubinemia of healthy and normal newborns, a clinical trial
Public title
The effect of Zinc on Hyperbilirubinemia of newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg/dL; age 3 to 7 days; using no other drug.
Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion.
Age
From 3 days old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commite of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
ZUMS.REC.1396.30
Health conditions studied
1
Description of health condition studied
Neonatal physiological jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Total and direct bilirubin of serum
Timepoint
One time measuring before prescribing of Zink and immediately after that daily measurment in three days
Method of measurement
Colorimetric method by Lathe and Ruthven
Secondary outcomes
empty
Intervention groups
1
Description
Daily administration of 5 mg twice daily Zinc supplementation in case group until the newborn is admitted
Category
Treatment - Drugs
2
Description
Daily administration of 5 mg twice daily placebo in control group until the newborn is admitted