Investigating the effect of oral zinc supplementation on the growth of infants
Design
A randomized double-blind clinical trial with control and intervention groups with parallel groups, on 60 infants. En Randomization with a table of random numbers by random allocation method.
Settings and conduct
This study is conducted as a randomized clinical trial on 60 babies born in Mobini Hospital in Sabzevar city in 1402 whose birth weight is 1500-2500 grams. The intervention group will be given two bottles, one containing zinc sulfate syrup and the other containing vitamins A and D. In comparison, the control group will be given two bottles, one containing vitamins A and D, and one placebo, distilled water. Consumption is explained to parents. The bottles are chosen the same way, the label is separated on the bottles and the name of the infant and the date are written on it.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Babies with a birth weight of 1500 to 2500 grams, singletons, no evidence of congenital malformations, no evidence of diseases that affect growth
Exclusion criteria: Parents' unwillingness to continue cooperation in the research and complications caused by supplement use, Not taking zinc supplements regularly, Diagnosing or diagnosing diseases that affect growth during the study
Intervention groups
Intervention group with zinc sulfate syrup and vitamins A and D
Main outcome variables
Height, weight, head circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240330061385N1
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Seyedeh Kobra Bagheri Nokashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 835 5320
Email address
s.bahar.b@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of zinc supplementation on the growth of infants with low birth weight
Public title
The effect of supplement use on the growth of infants with low birth weight
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Babies with a birth weight of 1500 to 2500 grams
Singletons
No evidence of congenital malformations
No evidence of diseases that affect growth
Exclusion criteria:
Parents' unwillingness to continue cooperation in the research
Complications caused by supplement use
Not taking zinc supplements regularly
Diagnosing or diagnosing diseases that affect growth during the study
Age
From 1 day old to 7 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using a table of random numbers in such a way that babies who are born every day with a birth weight of 1500 to 2500 grams are numbered from 1 to n, then from the randomization table, which consists of rows and columns 5-digit numbers are used for random selection. This table contains 5-digit numbers that are arranged completely randomly, and the middle digit is used for selection. At first, a 5-digit number is selected with eyes closed, and The diagonal face is drawn linearly with the origin of that number, the middle numbers of each 5-digit number are selected, if it is greater than n, it is removed, and this work continues until half of the eligible births of that day are selected. If we have a birth eligible for the study on one day, it will be added to the births of the next day and then a random selection will be made
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of the study will be of a double-blind type, so that the participants do not know that they are in the intervention group or the control group, as well as an expert who calls the parents every week to get information about how to use supplements and the condition of the infant. Also, the experienced statistical expert who measures the weight, height and head circumference of infants at the end of one month and two months of age is also unaware of the intervention and control group members. And they record the information in the infants' file and only the person analyzing the information knows about the members of the control and intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Sabzevar, Tohid Shahr Blvd., University Campus Building, Education Vice-Chancellor, Medical School
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.MEDSAB.REC.1402.123
Health conditions studied
1
Description of health condition studied
low birth weight newborn
ICD-10 code
P07.0
ICD-10 code description
low birth weight newborn
Primary outcomes
1
Description
Weight
Timepoint
At the beginning of the intervention (before the start of the study), 1 month old, two months old
Method of measurement
Digital scale
2
Description
Height
Timepoint
At the beginning of the intervention (before the start of the study), 1 month old, two months old
Method of measurement
Meter
3
Description
Head circumference
Timepoint
At the beginning of the intervention (before the start of the study), 1 month old, two months old
Method of measurement
Meter
Secondary outcomes
1
Description
fever
Timepoint
every week
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: The intervention group is given two bottles, one containing zinc sulfate syrup and the other containing vitamins A and D, and parents are taught how and how much to use. The name of the infant and the date are written on the bottles. The calculation of the daily intake is such that the intervention group receives 2 mg of zinc per kilogram of weight per day in addition to vitamins A and D.
Category
Treatment - Drugs
2
Description
Control group: The control group is given a bottle containing vitamins A and D and a placebo bottle containing distilled water, and how to use it is explained to the parents.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahidan Mobini Hospital
Full name of responsible person
Seyedeh Kobra Bagheri Nokashti
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 911 835 5320
Email
s.bahar.b@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyedeh Kobra Bagheri Nokashti
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 911 835 5320
Email
s.bahar.b@gmail.com
Grant name
Vice-chancellor in Research of Sabzevar University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahdi Jalili Akbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 915 571 1584
Email
jalilim566@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahdi Jalili Akbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 915 571 1584
Email
jalilim566@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyedeh Kobra Bagheri Nokashti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 911 835 5320
Email
s.bahar.b@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available