| November 12, 2016 |
summary |
Objective: The aim of this study is to determine the effects of vitamin D and calcium co-supplementation on inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-40 years with overweight diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 104 women with PCOS eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D/week and 1000 mg calcium/d co-supplement (intervention group: n=26), 50000 IU vitamin D/week supplement (intervention group: n=26), 1000 mg/d calcium supplement (intervention group: n=26) or placebo (control group: n=26). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure inflammatory factors and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks (July 1, 2014-Sebtember 1, 2014). Outcomes: Serum hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA) will be measured at baseline and end-of-trial.
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