The purpose of this study was to evaluate the effect of initiation of iron supplementation at the end of 4 months, compared to 6 months of age, on growth indices in infants.
Design
Randomized, blinded, sham controlled clinical trial with a parallel group design of 100 infants, 50 patients in the intervention group (starting an iron drop from 4 months) and 50 in the control group (starting the iron drop from 6 months of age ).
Settings and conduct
The aim of this study was to investigate the effect of early onset of iron supplementation on growth indices in infants (height, weight and head circumference) in specialty and postgraduate specialty clinic of Heshamateyeh Hospital in Sabzevar city. In this study, only those who evaluated the outcome in infants were unaware of how infants were grouped. Infants are randomly assigned to the intervention group (the start of iron drop at the end of 4 months of age at dosage of 2 mg/kg) and the control (starting the iron drop at the end of 6 months of age at dosage of 2 mg/kg). Growth index will be compared in two groups by the end of the 12th month.
Participants/Inclusion and exclusion criteria
Inclusion criteria consisted infants aged 4 to 12 months, gestational age greater than 37 weeks, birth weight more than 2500 grams and without congenital anomalies.
Intervention groups
Starting iron supplementation at the end of 4 months as an intervention group and from 6 months as a control group.
Main outcome variables
Infant growth indices (height, weight and head circumference) by the end of the 12th month
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180305038958N1
Registration date:2018-08-20, 1397/05/29
Registration timing:retrospective
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Zahra Khaksar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1300
Email address
khaksarZ89@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2018-06-11, 1397/03/21
Trial completion date
empty
Scientific title
Comparison of iron supplement effects on neonatal growth indexes, initiated from first 4th and 6th months of life: A randomized clinical trial
Public title
Comparison of initiation of iron supplementation at the end of 4 months and 6 months of age on height, weight and head circumference of infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infants 4 to 12 months old
Gestational age more than 37 weeks
Birth weight more than 2500 grams
Singleton
Exclusion criteria:
Congenital anomalies
History of addiction in mother
Age
From 4 months old to 12 months old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on permutation. Accordingly, 25 blocks were allocated to patients, in each block, 2 from A treatment group and 2 from B treatment group were placed. Eventually, after completion of the blocks, group A was treated with iron drops from 4 months of age and Group B received iron drops at 6 months of age.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups and the outcome evaluator is unaware of the groups. It should be noted that the participants can not be blinded to the intervention or control group.
Placebo
Not 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 University of Medical Sciences, Tohid Blvd, Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.MEDSAB.REC.1369.48
Health conditions studied
1
Description of health condition studied
Infant Growth Index
ICD-10 code
P61.3
ICD-10 code description
Congenital anaemia from fetal blood loss
Primary outcomes
1
Description
The weight of the infants
Timepoint
Weight measurement at birth and 2, 4, 6, 9 and 12 months
Method of measurement
Baby scales with a capacity of 20 kg with a precision of 20 g to 20 kg
Secondary outcomes
1
Description
The height of infant
Timepoint
Measuring height at birth and 2, 4, 6, 9 and 12 months
Method of measurement
Meters with millimeter precision
2
Description
Infant head circumference
Timepoint
Measuring head circumference at birth and 2, 4, 6, 9 and 12 months
Method of measurement
Meters with millimeter precision
Intervention groups
1
Description
Intervention group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the end of 4 months with a dose of 2 mg/kg until the end of 24 months of infancy
Category
Treatment - Drugs
2
Description
Control group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the 6 months of ages with a dose of 2 mg/kg until the end of 24 months of infancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshamati Hospital Clinic
Full name of responsible person
Seyed Mohsen Emami
Street address
Heshamati Hospital, Asadabad Ave., Sabzevar Twon
City
Sabzevar
Province
Razavi Khorasan
Postal code
5144011604
Phone
+98 51 4401 1601
Email
Mohsenemami007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Twon
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
omid693@yahoo.com
Web page address
Grant name
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
Seyed Mohsen Emami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
Mohsenemami007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Mohsen Emami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
Mohsenemami007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Khaksar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
KhaksarZ@medsab.ac.ir
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