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IRCT20160308026971N11 IRCT 2020-12-20 Rafsanjan University of Medical Sciences The effect of iron supplementation during menstrual bleeding on bleeding and hemoglobin level The effect of iron supplementation during menstrual bleeding on bleeding and hemoglobin level in students: A Randomized Clinical Trial 2020-11-04 anticipated 160 Complete https://irct.ir/trial/52990 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Taking iron supplements during menstrual bleeding. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Marzeyeh Loripoor
Faculty of Nursing and Midwifery, Nursing street
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 913 393 7334 marzeyehloripoor@yahoo.com Rafsanjan University of Medical Sciences scientific Marzeyeh Loripoor
Faculty of Nursing and Midwifery, Nursing street
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3428 0035 marzeyehloripoor@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) 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 15 years 45 years Female 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 Treatment - Drugs Treatment - Drugs 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. 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 Menstrual bleeding rate. Timepoint: Before the intervention and after each intervention (three menstrual cycles). Method of measurement: Higham chart (pictorial blood assessment chart). Blood hemoglobin level. Timepoint: Before the intervention and one week after taking the last iron pill or placebo. Method of measurement: blood test. Rafsanjan University of Medical Sciences Approved 2020-07-13 Ethics Committee of Rafsanjan University of Medical Sciences No. 33, Alley 41, Mostafa Khomeini St Rafsanjan Kerman Iran (Islamic Republic of)