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IRCT20240211060962N1 IRCT 2024-06-01 Oroumia University of Medical Sciences Investigating the effect of ferrous sulfate on thyroid function in pregnant women Investigating the effect of ferrous sulfate on thyroid function in pregnant women with acquired hypothyroidism in the second trimester of pregnancy 2024-04-20 anticipated 48 Complete https://irct.ir/trial/75534 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, we use a table of random numbers. Suppose we are conducting a study in which there are two groups A and B. We assign each odd number to group A and each even number to group B. We close our eyes and Place your finger in the table of random numbers and write down the number of its column and row and specify the direction of your movement in this table. Suppose our starting point is the number 5 at the intersection of column 07 and row 07 and the direction of our movement is horizontal. to the right, so the first patient with the number 5 receives treatment A and we continue in the same way until the end. The allocation of the next patient is not predictable and this allocation is not one in between, Blinding description: One way of blinding is the use of a placebo, that is, an inert substance that has the same taste and smell as Taher, although the use of a placebo in itself does not guarantee that the patients were blinded. 3 Primary acquired hypothyroidism. Intervention 1: Intervention group: At the beginning of the study, 5 cc of blood will be collected from each patient and for testing, it will be done using vidas kits for ferritin and thyroid hormones (one from each kit) and Ferozin method to check serum transferrin and iron (one kit from each). ) and it will be done in a laboratory (Kawsar Women's Comprehensive Laboratory in Urmia). Then, for the intervention group, ferrous sulfate tablets from Rosdaro Pharmaceutical Factory, each tablet containing 50 mg of elemental iron, will be given two tablets equivalent to 100 mg of elemental iron per day. After three months, 5 cc of blood will be collected from each group and the tests will be repeated in the same laboratory with the same kits. Intervention 2: Control group: At the beginning of the study, 5 cc of blood will be collected from each patient and for testing, it will be done using vidas kits for ferritin and thyroid hormones (one from each kit) and Ferozin method to check serum transferrin and iron (one kit from each). ) and it will be done in a laboratory (Kawsar Women's Comprehensive Laboratory in Urmia). And for the control group, two placebo pills will be given daily. After three months, 5 cc of blood will be collected from each group and the tests will be repeated in the same laboratory with the same kits. Yes - There is a plan to make this available What will be shared: In this study, only a part of the data, such as the information related to the main outcome or the like, can be shared after making people unidentifiable. When: The access period starts 3 months after the thesis defense To whom: The data of this study will be available only to researchers working in medical and scientific academic institutions Conditions: Ethical considerations should be observed in all relevant aspects and analyses Where to obtain: Send a message to email poormobinaa97@gmail How to obtain: Examining the person requesting information and the reason for his request for information, observing ethical considerations and checking in the university council, and sending the information if necessary. Comments:
public Mobina Pourghahramani
Hasani Street Kosar Hospital
Urmia Iran (Islamic Republic of) 5167869465 +98 44 3346 8815 pourmobinaaa97@gmail.com Oroumia University of Medical Sciences scientific Mobina Pourghahramani
Hasani Street Kosar Hospital
Urmia Iran (Islamic Republic of) 5167869465 +98 44 3346 8815 poourmobinaaa97@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age 20 to 35 years Second trimester pregnancy is considered Primary acquired thyroid disease Obtaining informed consent and explanation to patients The bmi of pregnant mothers is considered within the normal range (18.5-24.5) 20 years 35 years Female Having diabetes and high blood pressure Suffering from chronic diseases, including chronic kidney failure and liver failure Getting cancer and neoplasm, especially thyroid cancer Dissatisfaction of patients E01.8 Other iodine-deficiency related thyroid disorders and allied conditions Treatment - Drugs Placebo Intervention group: At the beginning of the study, 5 cc of blood will be collected from each patient and for testing, it will be done using vidas kits for ferritin and thyroid hormones (one from each kit) and Ferozin method to check serum transferrin and iron (one kit from each). ) and it will be done in a laboratory (Kawsar Women's Comprehensive Laboratory in Urmia). Then, for the intervention group, ferrous sulfate tablets from Rosdaro Pharmaceutical Factory, each tablet containing 50 mg of elemental iron, will be given two tablets equivalent to 100 mg of elemental iron per day. After three months, 5 cc of blood will be collected from each group and the tests will be repeated in the same laboratory with the same kits. Control group: At the beginning of the study, 5 cc of blood will be collected from each patient and for testing, it will be done using vidas kits for ferritin and thyroid hormones (one from each kit) and Ferozin method to check serum transferrin and iron (one kit from each). ) and it will be done in a laboratory (Kawsar Women's Comprehensive Laboratory in Urmia). And for the control group, two placebo pills will be given daily. After three months, 5 cc of blood will be collected from each group and the tests will be repeated in the same laboratory with the same kits. Primary outcome variable: pregnant women with primary acquired hypothyroidism or those whose tsh is greater than 4.5 mlU/L. Timepoint: Measurement of thyroid hormones at the beginning of the intervention (before the start) and 2 months after the start of ferrous sulfate. Method of measurement: The method of measurement is through laboratory tests, 5 cc of blood will be taken from each patient, and for the test, vidas kits for thyroid hormones will be taken. My financial source is a student, and because I am a campus student, no fees are charged by the university. Approved 2024-01-29 Urmia University of Medical Sciences (Research Ethics Committee) Hasani Street, Kosar Hospital Urmia West Azarbaijan Iran (Islamic Republic of)