Purpose: Evaluation of the effect oral zinc on the serum bilirubin levels in term neonates. All the newborns with an age of more than 72 hours that had been referred to Amirkola Children's Hospital (ACH) with serum bilirubin level more than 15mg/dl have been considered as the case group and received phototherapy according to the ACH phototherapy protocol. On the other hand newborns with serum bilirubin level more than 15mg/dl have been considered as control group. In both groups phototherapy were done according to the ACH phototherapy protocol. Bilirubin was cheeked by spectrophotometry method by chemical kits and serum zinc level was checked by auto analyzer; in two times before the photo therapy start and at the discharge time. By choosing 30 cases in the each group it would be possible to detect the effect of one unit differences between the case and control group, with 95 percent confidence interval and 80 percent ability test. The study is double blinded; study phases are trial 1 and 2 done in one center (Amirkola Children's Hospital). Performed via a random number table. Inclusion criteria: Full term newborns, with of age for more than 72 hours and serum bilirubin level more than 15mg/dl. Exclusion criteria: All babies who received medication such as zinc sulphate and phenobarbital by mothers or newborn. Intervention: Oral zinc administration. The primary consequences: Determination of serum bilirubin level. The secondary consequence: detecting serum zinc levels that would be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072629077N1
Registration date:2017-03-16, 1395/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
bahram ranjbar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
b.ranjbar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral zinc administered on the bilirubin serum level in the icterus mature newborns
Public title
The effect of oral zinc administered on the bilirubin serum level in the icteric mature newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Full term newborns; with of age for more than 72 hours & serum bilirubin level more than 15 mg/dl.
Exclusion criteria: All babies who received medication such as zinc sulphate & phenobarbital by mothers or newborn
Age
From 3 days old to 28 days old
Gender
Both
Phase
1-2
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
-
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences Ethics Committee
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran Babol
City
Babol
Postal code
4717647745
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
MUBABOL,HRI.REC.1395.27
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Serum bilirubin's level
Timepoint
Total serum bilirubin level at the time of admission, daily during the hospitalization and at the time of the discharge
Method of measurement
Measuring of the total serum bilirubin level by biochemistry kits manufactured in Iran and by the method of spectrophotometry.
Secondary outcomes
1
Description
Serum zinc's level
Timepoint
At the time of admission and discharge
Method of measurement
Auto analyser
Intervention groups
1
Description
Administration of 5mg of zinc sulfate BD/per day in the treatment group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Dr Bahram Ranjbar
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, IR Iran.
City
Amirkola, Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences
Full name of responsible person
Dr Ali Akbar Moghaddamnia
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran
City
Babol
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 Technology Affairs, Babol 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
Amirkola Children’s Hospital
Full name of responsible person
Dr Bahram Ranjbar
Position
Pediatrician
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 981132346963
Email
b.ranjbar@mubabol.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Dr Mousa ahmadpour-Kacho
Position
Neonatologist
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
mousa_ahmadpour@hotmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Dr Bahram Ranjbar
Position
Pediatrician
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province 4731741151, IR Iran
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 981132346963
Email
b.ranjbar@mubabol.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)