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November 12, 2016 Expected recruitment end date 2015-08-22
November 12, 2016 Expected recruitment start date 2015-08-12
November 12, 2016 summary Objective: The aim of the current study is to evaluate the effects of carnitine supplementation on metabolic profiles in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, anti-diabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either carnitine supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles. Start and end date of intervention: 12 weeks (August 23, 2015-November 21, 2015). Outcomes: Metabolic profiles will be measured at study baseline and after 12 weeks of intervention.
November 12, 2016 Date approved 1 2015-08-02
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