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IRCT2015082111335N6 IRCT 2015-12-27 Tabriz University of Medical Sciences The effect of cholecalciferol supplementation on angiogenic factors in breast cancer survivors co-administered with tamoxifen The effect of cholecalciferol supplementation on serum levels of vascular endothelial growth factor-A and angiopoietin-2 in breast cancer patients co-administered with tamoxifen: a randomized controlled clinical trial 2016-01-25 anticipated 40 Complete https://irct.ir/trial/11603 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block random allocation was performed using a statistical software program, Blinding description: Eligible patients were randomly assigned to the intervention and placebo groups. Packages containing cholecalciferol capsules were encoded in B and C to ensure that there is uninformed status for grouping in this study. Sampling in two groups of intervention and placebo was done by Random allocation software. Checking the eligibility of the participants and placing in the intervention and placebo groups was done by researcher who was unaware of the grouping and the type of supplements that they received during the study. The intervention group received 50000 IU cholecalciferol per week and the placebo group received capsules containing liquid paraffin that they were similar in appearance, size, color, and odor to cholecalciferol capsules. Patients, researcher and laboratory staff were unknown to the distribution of cholecalciferol and placebo. 2 Breast cancer. Intervention 1: Intervention group: supplement therapy with a soft-gel of 50000 IU cholecalciferol(vitamin D) per week for 8 weeks the duration of intervention. The soft-gel produced by Zahravi pharmaceutical. Intervention 2: Placebo: Placebo soft-gel typically similar to vitamin D soft-gel in size, color and odor. BC patients will use a soft-gel that contain liquid paraffin every week for the duration of 8 weeks. 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 There was not more information.
public Saeed Pirouzpanah
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neyshabori St, Golgasht St
Tabriz Iran (Islamic Republic of) 51665118 +98 41 3335 7580 pirouzpanah@gmail.com Tabriz University of Medical Sciences scientific Saeed Pirouzpanah
Nutrition faculty, Tabriz University of Medical Sciences, Attar neyshabori Ave., Golgash Ave.
Tabriz Iran (Islamic Republic of) 51665118 +98 41 3335 7580 pirouzpanah@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The range of body mass index (BMI) is 20 to 35 kg/m2 30 – 65 years old histopathologic confirmed breast malignancy histopathologic grades of 2 and 3 tendency to participate in study completed questionnaire tamoxifen consumption 30 years 65 years Female Being at clinical stage 4 pregnancy lactation acute renal or liver failure using antiepileptic medications and contraceptive drugs history of hormonal related diseases (such as diabetes, hyperthyroidism and poly cystic ovary syndrome) nausea vomiting headache vertigo C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: supplement therapy with a soft-gel of 50000 IU cholecalciferol(vitamin D) per week for 8 weeks the duration of intervention. The soft-gel produced by Zahravi pharmaceutical. Placebo: Placebo soft-gel typically similar to vitamin D soft-gel in size, color and odor. BC patients will use a soft-gel that contain liquid paraffin every week for the duration of 8 weeks. Serum levels of angiopoietin-2 and VEGF-A. Timepoint: Baseline and 8 week after baseline. Method of measurement: ELISA. Anthropometric parameters. Timepoint: Baseline and 8 week after baseline. Method of measurement: Waist circumference, body mass index (kg/m2), and waist to hip ratio. Tabriz University of Medical Sciences Approved 2015-09-16 The Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabori St., Tabriz East Azarbaijan Iran (Islamic Republic of)