The comparison of effectiveness of monthly and weekly prescription method of iron complementary on Hemoglobin level and Mood of girl students : A Randomized, double blind controlled trial
The aim of this study is to comparison between two method of iron complementary prescription on the level of hemoglobin and mood in girl students. This study is a Randomized, double blind controlled trial . Participants are girl students living in dormitories of Tabriz University of Medical Sciences. The main inclusion criterion includes hemoglobin below 12 gr/dl an the main exclusion criterion is the diagnosis of other types of anemia during the study. The number of participants will be 225. After signing conscious consent and taking blood samples from students (by laboratory) those whose hemoglobin level is under 12g/dl will enter the study. Participants in 3 groups will receive weekly iron complementary, menstrual iron complementary and placebo. Weekly iron complementary group will receive iron pills, once every week and placebo will be taken in the first 4 days of each menstrual bleeding period. Menstrual iron complementary group will be taken iron pills in the first 4 days of each menstrual bleeding period and placebo in a specific day every week. Placebo group will receive a pill (the same color as iron pill) in the first 4 days of each menstrual period and receive the other color (the same color as iron pill) in a specific day weekly. The intervention will last 4 month. After intervention, the level of hemoglobin and mood status will be compared between 3 groups before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210137618N4
Registration date:2012-11-06, 1391/08/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Soheila Bani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
banis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-10, 1391/08/20
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of monthly and weekly prescription method of iron complementary on Hemoglobin level and Mood of girl students : A Randomized, double blind controlled trial
Public title
The effects of iron complementary on hemoglobin level and mood
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Students living in dormitories of Tabriz university of medical sciences, Not using vitamin and iron complementary in the last 3 month, Not using oral or injection steroidal hormones, Not using IUD, Not existence of a hepatic, infectious or parasitic diseases in the time of study, Not existence of hematologic disorders such as thalassemia or hemophilia, any contraindication iron complementary, Not existence psychological disorders, Not existence systemic disorders which can affect menstrual bleeding such as diabetes, thyroid disorders, hyperadrenalism,… , participants with signs and symptoms of anemia which investigator finds in clinical examination( assessing color of mucosa, nails, conjunctive), participants with hemoglobin below 12g/dl.
Exclusion criteria: Not being interested to continue (leaving study), diagnosis of other types of anemia during the study, diagnosis of systemic, infectious, parasitic or hepatic disorders during study.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
225
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Tabriz University of Medical Sciences
Street address
Tabriz, Golgasht st, Tabriz University Of Medical Sciences, No 2 Building, 3 floor, Deputy Of Research
City
Tabriz
Postal code
51665118
Approval date
2012-10-15, 1391/07/24
Ethics committee reference number
91111
Health conditions studied
1
Description of health condition studied
Anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anaemia
Primary outcomes
1
Description
Hemoglobin level
Timepoint
Once before the intervention and second time 4 months after beginning the intervention
Method of measurement
Based on result laboratory by Cell counter device model H1
2
Description
Mood
Timepoint
Once before the intervention and second time 4 months after beginning the intervention
Method of measurement
Based on POMS SF questionnaire
Secondary outcomes
1
Description
Menstrual bleeding level
Timepoint
Once before the intervention and second time 4 months after beginning the intervention
Method of measurement
Based on Higham questionnaire
Intervention groups
1
Description
Intervention group: Ferfolic pills containing 60 mg ferrous sulfat and 400 µg folic acid, Will be used in one group one pill every week and the other group, one pill in the first 4 days of menstrual bleeding period up to 4 month (16 week).
Category
Treatment - Drugs
2
Description
Control group: Placebo contains pharmacologically useless substances such as lactose, starch and Avisel (micro crystalin selulose), This materials are used for pharmacological and non pharmacological (placebo) pills. Placebo will be used in one group, one pill every week and the other group one pill in the first 4 days of menstrual bleeding period and in placebo group the both weekly and in the first 4 days of menstrual bleeding up to 4 month (16 week).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar dormitoy of Tabriz University of Medical Sciences
Full name of responsible person
Ayemeh Hassanpour seiah estalkhi, Master of sciences student in midwifery
Street address
Kosar dormitoy, end of South Shariati street, side of Faculty of Nursing and Midwifery
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Sakineh Mohamad Alizadeh
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ayemeh Hassanpour seiah estalkhi
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
Email
hayemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sohiela Bani
Position
Master of Sciences in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
Email
Banisoheila@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Ayemeh Hassanpour seiah estalkhi
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
hayemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)