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To evaluate the effect of Zinc sulfate on growth indexes and hepatitis B antibody titer in premature neonates

Protocol summary

Summary
The purpose of this investigation is to determine the effect of Zinc sulfate on growth indexes(weight ,height ,head circumference), and hepatitis B antibody titer in 28-36 week old premature neonates, born in Imam Reza and Motazedi hospitals of kermanshah. In an incidental trial, 146 neonates having no organic disease and fed only by breast milk, were entered into the study. In case of the appearance of any sign of disease, they were excluded. The newborns were divided into two groups, case and control, in a totally random fashion. The former were given 3 ml of the Zinc sulfate containing 3 mg elemental Zinc, every day for 6 months, while the latter received nothing. The weight, height and head circumference of both groups were measured at birth and both were received hepatitis B vaccine. The growth and development indexes were checked every month in both groups. The hepatitis B vaccination was done routinely in both of them .The antibody titer and the indexes were evaluated one month after the vaccination done 6th month. The results were analyzed in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010255008N1
Registration date: 2010-11-21, 1389/08/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-11-21, 1389/08/30
Registrant information
Name
Shokoufe Ahmadipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6304
Email address
shahmadipour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research affairs management of Kermanshah University of Medical Sciences
Expected recruitment start date
2010-10-07, 1389/07/15
Expected recruitment end date
2011-02-19, 1389/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of Zinc sulfate on growth indexes and hepatitis B antibody titer in premature neonates
Public title
To evaluate the effect of Zinc sulfate on growth indexes and hepatitis B antibody titer in premature neonates
Purpose
Diagnostic
Inclusion/Exclusion criteria
The inclusion criteria: 28-36 gestational age , lack of congenital or organic disease, breast feeding. The exclusion criteria : Formula feeding, congenital or organic disease, contracting any disease during study, taking Zinc sulfate irregularly .
Age
From 28 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd.
City
Kermanshah
Postal code
67155-1469
Approval date
2010-10-05, 1389/07/13
Ethics committee reference number
420/6969/ 7/پ

Health conditions studied

1

Description of health condition studied
Zinc deficiency
ICD-10 code
E60
ICD-10 code description
Dietary zinc deficiency

Primary outcomes

1

Description
Weight
Timepoint
birth time and monthly
Method of measurement
Pan scale

2

Description
lenght
Timepoint
birth time and monthly
Method of measurement
lenght scale

3

Description
head Circumference
Timepoint
birth time and monthly
Method of measurement
meter

4

Description
Antibody titer
Timepoint
1 month after injection of hepatit B vaccin at six month after birth
Method of measurement
Elisa method

Secondary outcomes

empty

Intervention groups

1

Description
control group: nothing
Category
N/A

2

Description
case group: 3 mg of zinc sulfate, daily for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonate part, Imam Reza Hospital
Full name of responsible person
Dr. Mitr Hemmati
Street address
University St., Shahid Shiroudi Blvd.
City
Kermanshah

2

Recruitment center
Name of recruitment center
Neonate part, Mo'tazedi Hospital
Full name of responsible person
Dr. Mitr Hemmati
Street address
Ferdousi Sq.
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research affairs management, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Keyghobad Ghadiri
Street address
Shahid Beheshti Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research affairs management, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitr Hemmati
Position
Assistant professor/M.D.
Other areas of specialty/work
Street address
University St., Shahid Shiroudi Blvd.
City
Kermanshah
Postal code
6714415333
Phone
+98 831423763015
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
http://www.kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitr Hemmati
Position
Assistant professor/M.D.
Other areas of specialty/work
Street address
University St., Shahid Shiroudi Blvd.
City
Kermanshah
Postal code
6714415333
Phone
+98 831423763015
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
http://www.kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitr Hemmati
Position
Assistant professor/M.D.
Other areas of specialty/work
Street address
University St., Shahid Shiroudi Blvd.
City
Kermanshah
Postal code
6714415333
Phone
+98 831423763015
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
http://www.kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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