A Comparative Study of the Effect of Iron Supplements in Ferrous Sulfate and Ferrous Gluconate on Prophylaxis of Iron Deficiency in 6-24 Months Children Referring to Amirkabir Hospital in Arak
Comparison of ferrous sulfate and ferrous gluconate supplementation with iron supplementation in prophylaxis of iron deficiency in children 6 to 18 months old referred to Amir Kabir hospital in Arak
Design
This study is a randomized clinical trial that will be conducted as a single blind. Are blind. In this study, 120 healthy 6- to 18-month-old children (two groups of 60 each) were recruited using the easy-to-select based on the pair-wise and individual-based clinic design and divided into two groups of amilodipine and control groups.
Settings and conduct
This study is a randomized clinical trial that will be performed as single blind on all healthy children 6 to 18 months old referred to Amir Kabir Hospital in Arak. The statistician who manages the data analysis is blind to the groups, and the pediatrician, interns responsible for the study, and the families of the children participating in the study are aware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children referred to Amir Kabir Hospital in Arak who are 6 months to 18 months old with birth weight above 2500 gr and gestational age 42-37 weeks are fully term.
Exclusion criteria:
Children with underlying hematological disease or any anemia, birth weight less than 2500 grams and gestational age below 37 weeks, or infants who have not been breastfed since birth.
Intervention groups
In this study 120 healthy children 6 to 18 months of age were divided into two groups of 60 and iron supplemented for 6 months with 15 mg daily ferrous sulfate iron in one group and 15 mg ferrous gluconate iron in the other group.
A Comparative Study of the Effect of Iron Supplements in Ferrous Sulfate and Ferrous Gluconate on Prophylaxis of Iron Deficiency in 6-24 Months Children Referring to Amirkabir Hospital in Arak
Public title
The effect of ferrous sulfate and ferrous gluconate on the prevention of iron deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 months to 18 months.
Children with birth weight above 2500 gr and gestational age 42-37 weeks and full term
Exclusion criteria:
Children with underlying hematologic disease or any anemia
Children weighing less than 2500 grams and gestational age below 37 weeks
Infants who have not been breastfed since birth.
Children who have started iron supplementation earlier than 6 months due to birth defects or anemia.
Age
From 6 months old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 120 patients were recruited using the easy-to-select based on the pair-wise and individual-based clinic design and divided into two groups of amilodipine and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness is due to being single-blind so the statistician who analyzes the data is blind to the groups, and the pediatrician, interns in charge of the study, and the families of the children participating in the study are aware of the groups under study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Sq., Peyambar-e-azam Complex
City
اراک
Province
Markazi
Postal code
3819693345
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.ARAKMU.REC.1398.016
Health conditions studied
1
Description of health condition studied
Iron Deficiency
ICD-10 code
E61.1
ICD-10 code description
Iron deficiency
Primary outcomes
1
Description
ferritin serum level
Timepoint
Before intervention and 6 months later
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take 15 mg ferrous gluconate daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: Take 15 mg ferrous sulfate daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Sanaz Khodabakhshi
Street address
Parastar Sq., Shiroudi St.
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Sardasht Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Sanaz Khodabakhshi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 3, Sam Apartment, Arghavan Alley, Bagh-e-daryache St.
City
Isfahan
Province
Isfehan
Postal code
8176763331
Phone
+98 31 3786 1878
Email
s.khodabakhshi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sanaz Khodabakhshi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 3, Sam Apartment, Arghavan Alley, Bagh-e-daryache St.
City
Isfahan
Province
Isfehan
Postal code
8176763331
Phone
+98 31 3786 1878
Email
s.khodabakhshi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sanaz Khodabakhshi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 3, Sam Apartment, Arghavan Alley, Bagh-e-daryache St.
City
Isfahan
Province
Isfehan
Postal code
8176763331
Phone
+98 31 3786 1878
Email
s.khodabakhshi@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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