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IRCT2017091736244N1 IRCT 2017-11-10 Cancer Research Center, Shahid Beheshti University of Medical Sciences Vitamin D supplementation and breast cancer prevention Assessment the effect of vitamin D supplementation on plasma vitamin D levels, inflammatory and antioxidant biomarkers and factors associated with cell proliferation, differentiation, damage and appopotosis in breast cancer survivor 2016-02-02 anticipated 165 Complete https://irct.ir/trial/27153 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Breast Cancer Survivour. Supplement therapy with daily dose of 4000 IU cholecalciferol for 12 weeks.
public Dr. Seyed Hossein Davoudi
No 7, Hafezi st. Farahzadi Blv, Shahrake Gharb
Tehran Iran (Islamic Republic of) +98 21 2236 0662 hdavoodi1345@gmail.com 1) Cancer Research Center, Shahid Beheshti University of Medical Sciences 2) Department of Nutrition scientific Elham Kazemian
No 7, Hafezi st. Farahzadi Blv, Shahrake Gharb
Tehran Iran (Islamic Republic of) +98 21 2236 0662 kazemianelham@yahoo.com; kazemianelham@sbmu.ac.ir Department of Basic Sciences and Cellular and Molecular Nutrition, Faculty of Nutrition Sciences and Iran (Islamic Republic of) Inclusion criteria: Patients with breast cancer including invasive or in situ carcinoma whose cancer was approved through pathological examination; Women aged 25-65 years; BMI between 25 to 35 kg/m2; not using 1000 IU daily or 50000 IU weekly or 300000 intramuscular injection of vitamin D supplement for at least 4 months before the study; not using dietary, herbal or omega-3 supplements during the intervention period; Patients were diagnosed with breast cancer at least 6 months prior the study and treatment protocols including surgery, radiotherapy and chemotherapy were completed. Exclusion criteria: History of malabsorption syndrome, calcium metabolism disorder, gastrointestinal, renal, inflammatory (sarcoidosis, etc.) and other endocrinological diseases; Treatment for weight reduction; high levels of plasma vitamin D 25 years 65 years Female Treatment - Drugs Supplement therapy with daily dose of 4000 IU cholecalciferol for 12 weeks Plasma vitamin D level. Timepoint: Baseline and post- intervention. Method of measurement: ELISA. Oxidative stress biomarkers including Malondialdehyde (MDA), Total Antioxidant Capacity (TAC), Superoxide dismutase (SOD). Timepoint: Baseline and post- intervention. Method of measurement: ELISA and colorometic method. Inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), Tumor necrosis factor alpha (TNFα), Interleukin 6 (IL-6), β-Interferon (IFN-β). Timepoint: Baseline and post- intervention. Method of measurement: ELISA. Biomarkers associated with cell proliferation, differentiation, damage and apoptosis including Matrix metallopeptidase 9 (MMP-9), Plasminogen activator inhibitor-1 (PAI-1), 8-hydroxy-2'-deoxyguanosine (8-OHdG), E-cadherin, B-cell lymphoma2 (Bcl-2), Intercellular adhesion molecule 1 (ICAM-1), Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Baseline and post- intervention. Method of measurement: ELISA. Anthropometric indicators including Weight, Height, Body Mass Index (BMI), Waist Circumferences, Hip Circumferences, Body Composition. Timepoint: Baseline and post- intervention. Method of measurement: Digital scale,stadiometer, measuring tape. Metabolic profiles including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (TC), triglyceride (TG), Aspartate Aminotransferase (SGOT), glutamate-pyruvate transaminase (SGPT), Urea, Creatinine. Timepoint: Baseline and post- intervention. Method of measurement: Colorometic method. Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Faculty of Nutrition Sciences and Food Technology and National Nutrition and Food Technology Researc Cancer Research Center, Shahid Beheshti University of Medical Sciences Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Faculty of Nutrition Sciences and Food Technology and National Nutrition and Food Technology Researc Approved 2016-01-21 Ethics committee of faculty of Nutrition Sciences and Food Technology and National Nutrition and Foo No 7, Hafezi st. Farahzadi Blvd., Sharake Qods Tehran Iran (Islamic Republic of)