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IRCT201706075623N120 IRCT 2017-06-22 Arak University of Medical Sciences Effect of supplementation in treatment of women with polycystic ovary syndrome of IVF candidate Clinical trial of the effect of chromium supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome of IVF candidate 2017-05-23 anticipated 40 Complete https://irct.ir/trial/6150 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be done by the use of computer-generated random numbers, Randomization description: At study baseline, after ratification based on age and BMI, subjects will be randomly allocated into two groups to receive supplements or placebo. Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with polycystic ovary syndrome Individuals aged 18 to 40 years old 18 years 40 years Female Androgen-secreting tumors Thyroid dysfunction Diabetes or impaired glucose tolerance E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally. Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Using HOMA formula. Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Total antioxidant capacity. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry. Arak University of Medical Sciences Approved 2017-05-22 Ethics committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Arak Markazi Iran (Islamic Republic of)