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IRCT20100209003320N24 IRCT 2024-07-18 Tabriz University of Medical Sciences The effect of vitamin D3 on benign breast tumor The effect of vitamin D3 supplementation (cholecalciferol) on nutritional status, VDR gene expression, endocrine, metabolic, and adipokine parameters in patients with benign breast tumors:Randomized controlled clinical trial 2024-07-05 anticipated 48 Complete https://irct.ir/trial/75911 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be classified into two intervention groups (receivers of vitamin D and placebo receivers of oral liquid paraffin) based on age, BMI, and benign type (fibrocystic masses and fibroadenomas), provided that they have no malignant characteristics confirmed by ultrasound examination. Random sampling will be conducted using a random number table, and the selected samples will be allocated to each block and group, Blinding description: The study is designed as a triple-blind trial. Initially, random selection of the samples is conducted by the study designer, and a list is prepared. Then, the clinic staff, who are unaware of the allocation at the time of enrollment, execute this list. Participants are randomly assigned to two groups: those receiving the vitamin D supplement and those receiving the placebo (oral liquid paraffin). Blinding procedure: Participants: Are unaware of the type of supplement they receive (vitamin D or paraffin). Clinic staff: Responsible for delivering the supplements and placebos, and the packages are delivered in a uniform manner without any distinguishing labels. Laboratory personnel: Who analyze the test results, are unaware of the participants' group allocations. The supplement and placebo packages are prepared and distributed uniformly without any indication of their contents. Allocation codes are kept with the principal investigator until the end of the study, and none of the individuals involved in the study's execution are aware of these codes to minimize bias. 3 Benign breast disease. Intervention 1: Intervention group:Consume one pearl of vitamin D3 50,000 IU per week for 8 weeks. Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study. Intervention 2: Control group: One pearl of oral liquid paraffin per week for 8 weeks. In the control group, patients will receive one pearl of oral liquid paraffin per week for 8 weeks. The appearance of the placebo capsules will be identical to the vitamin D capsules in terms of color, shape, size, and packaging. Both vitamin D and placebo capsules will be obtained from Zahravi Pharmaceutical Company.Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: The access period starts 12 months after the results are published To whom: The data will be available only to people working in scientific institutions Conditions: The data of this study will be available to other researchers only for meta-analysis studies Where to obtain: Sanaz Asemani, email adress:asemanisanaz65@gmail.com Phon number: 09038553148 How to obtain: The applicant should provide a brief description of the aims and methods of Meta-analysis. His/her request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days. Comments:
public Dr. Mehrangiz Ebrahimi- Mameghani
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7584 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimi- Mameghani
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
tabriz Iran (Islamic Republic of) 5185747731 +98 41 3335 7584 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Histopathological evidence of BBT (fibrocystic, fibroadenoma, etc.) Age between 19 and 50 years At least two years since diagnosis willingness to cooperate and complete the informed consent form Serum vitamin D deficiency (less than 20 ng/ml) 19 years 50 years Female Malabsorption disorders (such as Crohn's disease, celiac disease), biliary tract obstruction Acute or chronic conditions (including various types of cancer, liver, kidney, and acute heart failure), hyperthyroidism, hormonal disorders prior to diagnosis (e.g., polycystic ovary syndrome (PCOS)), type 1 diabetes, hypoglycemia, adrenal gland disorders Grade 3 obesity A daily calorie intake of less than 800 or more than 3500 kcal/d Asthma Any benign lesions in other organs Pregnancy Lactation Chemotherapy Radiotherapy Hormone therapy Cystectomy surgery Use of glucocorticoid, anti-seizure, contraceptive, and HRT medications Consuming more than 2000 mg of cod liver oil Taking painkillers containing caffeine D24 Benign neoplasm of breast Treatment - Other Placebo Intervention group:Consume one pearl of vitamin D3 50,000 IU per week for 8 weeks. Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study Control group: One pearl of oral liquid paraffin per week for 8 weeks. In the control group, patients will receive one pearl of oral liquid paraffin per week for 8 weeks. The appearance of the placebo capsules will be identical to the vitamin D capsules in terms of color, shape, size, and packaging. Both vitamin D and placebo capsules will be obtained from Zahravi Pharmaceutical Company.Participants will be advised to maintain their usual lifestyle, including their habitual diet.All participants will begin a two-week run-in period before starting the intervention. During this period, participants are asked not to be exposed to direct sunlight for more than 15 minutes a day. Also, they are asked not to consume eggs more than twice a week. Patients are also advised to avoid sources of omega-3 oils, nuts (such as almonds and walnuts), fatty fish, and cod liver. Avoid foods containing methylxanthine, vitamin E supplement, evening primrose oil during this period and until the end of the study.All participants will receive calcium carbonate (500 mg) together with cholecalciferol (200 IU) (Ca/VitD) from the beginning to the end of the study. VDR gene expression. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Real time RT-PCR. Endocrine parameters. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: ELIZA. Metabolic parameters. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Enzymatic kits. Adipokines. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: ELIZA. Nutritional status. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: A 24-hour dietary recall in three days (one holiday and two working days) and valid food frequency questionnaire. Physical activity. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Physical activity questionnaire. Anthropometric status. Timepoint: Before the start of the intervention, 8 weeks after the start of the intervention (end of the intervention). Method of measurement: Centimeter, Scale. Tabriz University of Medical Sciences Approved 2024-06-12 Research Ethics Committees of Tabriz University of Medical Sciences Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)