Determining the effect of iron supplementation during menstrual bleeding on bleeding volume and hemoglobin level
Design
Clinical trial with control group, with parallel groups, 3-way blind, randomized, phase 3 on 160 people, cards or envelope shuffing function is used for randomization
Settings and conduct
Sampling will be done in Rafsanjan University of Medical Sciences. The iron pills and placebo will be packed with the codes 1 and 2. Samples, researcher and the analyzer will be unaware of the type of drug. The hemoglobin level is checked before the intervention and if samples are anemic they are removed. The duration of the study is 4 menstrual cycles. The first cycle is with no intervention, during which the samples record the amount of menstrual bleeding in the Higham chart. Iron pills and Plus Bo are given to samples to take 3 menstrual cycles. The first group takes iron pills in the first 4 days of menstrual bleeding 1 a day and the second group takes Plus Bo in the same way. Each cycle they fill the Higham chart. A week after taking the last iron or Plus Bo pill, hemoglobin level is measured again
Participants/Inclusion and exclusion criteria
Lack of vitamin intake and iron pills in the last 3 months/Lack of pregnancy and lactation/Lack of endocrine disorders like diabetes and thyroid problems/Hemoglobin greater than or equal to 12 grams per deciliter
Intervention groups
The intervention group takes ferrous sulfate pills containing 50 mg of iron ions in the first 4 days of menstrual bleeding and the control group receives Plus Bo in the first 4 days of menstrual bleeding.
Main outcome variables
There is no difference in the amount of menstrual bleeding in the intervention and control groups before the intervention and after each intervention.
There is no difference in the amount of hemoglobin in the intervention and control groups before the intervention and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026971N11
Registration date:2020-12-20, 1399/09/30
Registration timing:registered_while_recruiting
Last update:2020-12-20, 1399/09/30
Update count:0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iron supplementation during menstrual bleeding on bleeding and hemoglobin level in students: A Randomized Clinical Trial
Public title
The effect of iron supplementation during menstrual bleeding on bleeding and hemoglobin level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious and free written satisfaction to participate in the study
Lack of vitamin intake and iron supplementation in the last three months
Lack of pregnancy and lactation
Not using oral and injectable steroid hormonal drugs
Lack of known parasitic and infectious diseases
Lack of blood diseases such as thalassemia and hemophilia
No known history of psychiatric disorders
Lack of endocrine disorders such as diabetes and thyroid problems
Lack of Contraindications Iron Consumption: Receiving blood frequently -Intake of intravenous iron-absorption disorder and excessive iron storage such as hemochromatosis
Not being a smoker
Not taking mineral supplements at the moment
Not taking herbal medicines and supplements for two weeks before the start of the study and throughout the study
BMI between 18.5 to 25 kg / m2
Hemoglobin greater than or equal to 12 grams per deciliter (not being anemic)
Having a normal menstrual cycle between 21-35 days and no known history of menorrhagia
Not having a recent history of major surgery and an accident leading to a blood transfusion
Lack of digestive problems (risk of iron deficiency disorders)
-No use of tampons or menstrual cups
Exclusion criteria:
The occurrence of allergic reactions to iron tablets
Forget about taking more than one iron pill per cycle
Take emergency contraceptive pills in each cycle
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating individuals to two intervention and control groups will be randomly simple and using a lottery. Put 80 sheets of paper with code 1 and 80 pieces of code 2 in a bowl and mix well. Each participant is asked to remove one of the sheets from the container so that they are randomly assigned to one of the iron pill use groups in the first 4 days of menstrual bleeding or the use of Plus Bo in the first 4 days of menstrual bleeding.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The manufacturer of the drug, taking into account codes 1 and 2, closes the iron and pharmaceutical tablets and provides them to the participants in the project by a researcher or information collector.
Questionnaires 1 and 2 will also be specified in the questionnaires. The completed questionnaires are then provided to the statistical consultant for analysis, and at the end, after the results have been determined, iron tablets and pharmaceuticals are identified. Thus, the women participating in the project, the researcher, the information gathering colleague and the statistical consultant of the type of medicine will be unaware and study the three Socors.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
No. 33, Alley 41, Mostafa Khomeini St
City
Rafsanjan
Province
Kerman
Postal code
7714668168
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.RUMS.REC.1399.077
Health conditions studied
1
Description of health condition studied
Taking iron supplements during menstrual bleeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Menstrual bleeding rate
Timepoint
Before the intervention and after each intervention (three menstrual cycles)
Method of measurement
Higham chart (pictorial blood assessment chart)
2
Description
Blood hemoglobin level
Timepoint
Before the intervention and one week after taking the last iron pill or placebo
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ferrous sulfate iron tablets containing 50 mg of iron ions are prepared by Amin Pharmaceutical Company. The intervention group will be given 12 iron pills to take three menstrual cycles. The time to take iron pills is in the first 4 days of menstrual bleeding.
Category
Treatment - Drugs
2
Description
Control group: Control group: Ferrosulfate iron tablet placebo is provided by Amin Pharmaceutical Company. The control group will be given 12 placebos for three menstrual cycles.The time of taking the placebo is in the first 4 days of menstrual bleeding
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan University of Medical Sciences
Full name of responsible person
Elnaz Mokhtarkalimi
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
info@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
marzeyeh loripoor
Street address
Central Organization of Rafsanjan University of Medical Sciences and Health Services, Deputy of research and technology, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 913 393 7334
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Email
marzeyehloripoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Email
marzeyehloripoor@yahoo.com
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