Determining effectiveness of national program of iron and vitamin D supplementation among secondary female students in Gonabad
Design
This study will be conducted on 180 female students of the 7th-grade girl. Clinical examinations for the screening of iron deficiency anemia by a doctor of the same sex and blood sampling by a trained person of the same sex
will be performed and the blood samples will be tested. Then Ferrous Fumarat iron tablets will be used weekly for 16 consecutive weeks and Pearl vitamin D3 for 9 months (one month each month).
After the intervention, the subjects will again be screened for clinical signs of iron deficiency anemia. Blood samples will be tested. The results of blood tests will be compared before and after the supplementary intervention program.
Settings and conduct
This study was conducted on 7th grade female students in Gonabad city (a city in the southeastern province of Khorasan Razavi, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria: student in seventh grade, resident of Gonabad city, willingness to participate in the study. Exclusion criteria: Students who participate in the pre-test but do not present in the post-test,
students who change their school
Intervention groups
In this study, Ferrous Fumarat iron tablets are taken weekly for 16 consecutive weeks and perl vitamin D3 for 9 months (one month each month).
Main outcome variables
The level of iron and vitamin D will be measured
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180722040559N3
Registration date:2018-11-24, 1397/09/03
Registration timing:retrospective
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Alireza Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 4548
Email address
jafaria962@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of national program of iron and vitamin D supplementation among secondary female students in Gonabad
Public title
Effectiveness of national program of iron and vitamin D supplementation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students in seventh grade
Residents of Gonabad city
Willingness to participate in the study
Exclusion criteria:
Students who participated in the pre-test but will not be present in the post-test
Changing their schools
Age
From 12 years old to 14 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Imam Khomeini street, Gonabad city, Razavi Khorasan
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Approval date
2015-09-01, 1394/06/10
Ethics committee reference number
SDH / 2 / 011
Health conditions studied
1
Description of health condition studied
Use of vitamin D and iron supplements
ICD-10 code
Z72.4
ICD-10 code description
Inappropriate diet and eating habits
Primary outcomes
1
Description
Increased levels of iron and vitamin D
Timepoint
After a period of 9 months and the end of the intervention,
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Students will receive ferrous fumarate tablets weekly for 16 consecutive weeks and perl vitamin D3 for 9 months (one month each month).
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools in Gonabad
Full name of responsible person
Alireza Jafari
Street address
Gonabad University of Medical Sciences, Imam Khomeini street
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3514
Email
jafaria962@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Street address
Gonabad University of Medical Sciences, Imam Khomeini street
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3514
Email
jafaria962@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Study data can be reported after unidentifiable participants in the study
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Alireza Jafari: jafaria962@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email