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IRCT20191130045556N1 IRCT 2020-01-12 Ahvaz University of Medical Sciences Melatonin and magnesium in polycystic ovary syndrome Investigating the Effect of melatonin and magnesium co-supplementation on metabolic, hormonal, inflammatory parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome 2019-12-22 anticipated 84 Complete https://irct.ir/trial/43873 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 84 subjects, 21 blocks will be generated using the online site (www.sealedenvelope.com). Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable, Blinding description: For blinding and unawareness of participants and investigator, unique codes will be used on the drug boxes. melatonin, magnesium, and placebo tablets will be placed into identical containers by an independent third party. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable. 3 Polycystic Ovarian syndrome. Intervention 1: Intervention group: Two melatonin tablet 3 mg (Nature Made, USA), Daily+ a magnesium tablet (each tablet containing 250 mg magnesium in the form of magnesium oxide) (Jalinous, Iran), daily, for 8 weeks. Intervention 2: Intervention group: Two melatonin tablet 3 mg (Nature Made, USA), Daily+ a magnesium placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks. Intervention 3: Intervention group: a magnesium tablet (each tablet containing 250 mg magnesium in the form of magnesium oxide) (Jalinous, Iran), daily+Two melatonin placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks. Intervention 4: Control group: Two melatonin placebo (Pharmacy Faculty, Tabriz, Iran), daily+ a magnesium placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks. Yes - There is a plan to make this available What will be shared: Demographic and primary outcomes data of participants When: Accessibility to data is possible 6 months after publication To whom: Researchers who are working in academic institutes Conditions: Only observation of documents is allowed; Analysis and use of data is not possible. Where to obtain: 1. Dr. Majid Karandish, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences,mkarandish@yahoo.com 2. Reihaneh Mousavi, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Re_mousavi@yahoo.com. How to obtain: The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person. Comments:
public Reihaneh Mousavi
Golestan Highway
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8253 re_mousavi@yahoo.com Ahvaz University of Medical Sciences scientific Majid Karandish
Golestan Highway
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3336 2414 mkarandish@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with polycystic ovary syndrome based on Rotterdam criteria Age 18-40 years BMI≤35 Tendency to participate in the study 18 years 40 years Female Pregnancy Lactation Sleeping disorders The night shift workers َََAny disease that affects metabolic parameters in this trial including Cushing's Syndrome, hypoglycemia, type I or II Diabetes, androgen secreting tumors or congenital adrenal hyperplasia, hyperprolactinemia, hyperparathyroidism, Thyroid disorders, hypertension, Anemia, Allergy, Asthma, Cardiovascular, Kidney, Liver or Pulmonary diseases, Cancer Any drugs that may cause side effects such as menstrual disorders, hirsutism or acne or drugs that affect plasma androgen levels, lipid profile, blood glucose or inflammatory factors during the last 3 months (such as oral contraceptives (OCP), Ovulation induction, anti-androgenic, insulin-sensitizer, blood glucose lowering, anti-obesity, antidepressants, anti-coagulants, Thiazides, Corticosteroids, Metformin, Lipid lowering, NSAIDs, Aspirin) Following the special diet Weight loss of more than 5% body weight in the last 6 months Taking melatonin, magnesium, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment Taking melatonin, magnesium, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment Smoking Alcohol consumption Migration Unwillingness to continue cooperation E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group: Two melatonin tablet 3 mg (Nature Made, USA), Daily+ a magnesium tablet (each tablet containing 250 mg magnesium in the form of magnesium oxide) (Jalinous, Iran), daily, for 8 weeks Intervention group: Two melatonin tablet 3 mg (Nature Made, USA), Daily+ a magnesium placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks Intervention group: a magnesium tablet (each tablet containing 250 mg magnesium in the form of magnesium oxide) (Jalinous, Iran), daily+Two melatonin placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks Control group: Two melatonin placebo (Pharmacy Faculty, Tabriz, Iran), daily+ a magnesium placebo (Pharmacy Faculty, Tabriz, Iran), daily, for 8 weeks Serum level of melatonin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Serum level of magnesium. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Fasting blood sugar. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Insulin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Insulin resistance. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: insulin resistance formula (HOMA-IR). Serum triglyceride. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Serum Low Density lipoprotein -Cholesterol (LDL-C). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Serum high Density lipoprotein -Cholesterol (HDL-C ). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Serum total cholesterol. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Total Testosterone. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Sex hormone-binding globulin (SHBG). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Free androgen index. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: formula. Total antioxidant capacity (TAC). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Chemical method. Serum level of Malondialdehyde (MDA). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Thiobarbituric acid method. Serum level of tumor necrosis factor alpha (TNF-α). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Serum level of High sensitivity C- Reaction Protein (hs-CRP). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Serum level of leptin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Sleep quality. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI). Grading of hirsutism. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Ferriman-Gallwey Questionnaire. Body mass index (BMI). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: BMI Formula. Waist circumference. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Tape. Tabriz University of Medical Sciences Ahvaz University of Medical Sciences Tabriz University of Medical Science Approved 2019-11-23 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan high way., Ahvaz Jundishapur University of Medical Sciences., Ahvaz., Iran Ahvaz Khouzestan Iran (Islamic Republic of)