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IRCT2017070433941N3 IRCT 2017-07-31 Kashan University of Medical Sciences Effect of carnitine supplementation in treatment of women with polycystic ovary syndrome Clinical trial of the effect of carnitine supplementation compared with the placebo on carotid intima-media thickness and biomarkers of inflammation in women with polycystic ovary syndrome 2016-07-11 anticipated 60 Complete https://irct.ir/trial/26045 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after balanced blocked randomization, subjects will be randomly divided into two groups to take either carnitine supplements (n = 30) or placebo (n =30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. N/A Polycystic ovary syndrome. Intervention 1: Intervention group: 250 mg carnitine (Avecina, Tehran, Iran), once a day, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 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) 81151-87159 +98 36 1534 3570 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with polycystic ovary syndrome according to Rotterdam criteria Aged 18 to 40 years 18 years 40 years Female Pregnant women Elevated levels of prolactin Endocrine diseases E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: 250 mg carnitine (Avecina, Tehran, Iran), once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. Mean left CIMT. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sonography. Maximum left CIMT. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sonography. Mean right CIMT. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sonography. Maximum right CIMT. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Sonography. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2016-07-10 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)