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IRCT20130903014551N9 IRCT 2020-10-18 Esfahan University of Medical Sciences Effect of magnesium on poly cystic ovary syndrome effect of magnesium supplementation on menstrual disorders, androgenic alopecia, quality of life and acne in women with poly cystic ovary syndrome 2020-10-22 anticipated 70 Complete https://irct.ir/trial/50264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through block randomization method (permuted blocked randomization). depending on the sample size , each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient, Blinding description: For double blinding of this study, at the beginning, cans contained magnesium supplement and placebo were coded as A and B by person other than researcher to ensure researcher and participants were not informed about types of supplement received by participants. N/A poly cystic ovary syndrome. Intervention 1: Intervention group: Patients in this group will receive 250 mg magnesium supplement made by Donya Daru Sepehr Company once a day for 10 weeks. Intervention 2: Control group: Patients in this group will receive a placebo that contains starch and is made by Barij Essanss Company once a day for 10 weeks. 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 I haven't made a decision yet
public Mahsima Jaripur
sepah
kashan Iran (Islamic Republic of) 8714683561 +98 31 5546 1381 mahsimajaripur@ut.ac.ir Esfahan University of Medical Sciences scientific Mohamad Hossein Rohani
Food and nutrition faculty, Isfahan medical university, hezar jarib street, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 s_m_rouhani2003@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women 18 to 45 years old with PCOS BMI between 5/18 to 30 Do not change the dose of the drug or start taking a new drug in the last two weeks Absence of menopause Absence of hypothyroidism Do not take vitamin and mineral supplements 18 years 45 years Female Failure to follow nutritional recommendations and interventions Failure to refer the person in the next steps Change the dose of the drug or start taking a new drug that affects the indicators of the study Having a specific disease that disrupts the study process Occurrence of menopause E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Intervention group: Patients in this group will receive 250 mg magnesium supplement made by Donya Daru Sepehr Company once a day for 10 weeks. Control group: Patients in this group will receive a placebo that contains starch and is made by Barij Essanss Company once a day for 10 weeks. Menstrual disorder. Timepoint: Before and after intervention. Method of measurement: Based on standard definitions provided by the International Federation of Gynecology and Obstetrics. Androgenic alopecia. Timepoint: Before and after intervention. Method of measurement: Sinclair Scale. Quality of life. Timepoint: Before and after intervention. Method of measurement: Health Survey Questionnaire (SF-36. Acne. Timepoint: Before and after intervention. Method of measurement: GAGS (global acne grading system) method. Number of ovarian cysts. Timepoint: At the beginning and end of the intervention. Method of measurement: sonography. Physical activity. Timepoint: In the second,forth,sixth,eighth and tenth weeks. Method of measurement: Physical activity record questionnaire. Dietary intake. Timepoint: In the second,forth,sixth,eighth and tenth weeks. Method of measurement: food record. Serum magnesium concentration. Timepoint: At the beginning the intervention, In the fifth week of the intervention. Method of measurement: AAS method. Esfahan University of Medical Sciences Approved 2020-10-03 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, Building No. 4 - Vice Chancellor for Research and Technology esfahan Isfehan Iran (Islamic Republic of)