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IRCT20180922041089N3 IRCT 2019-09-03 Tehran University of Medical Sciences The effect of vitamin D on the treatment of prostate hypertrophy The effect of vitamin D supplements on benign hypertrophy 2018-11-22 anticipated 54 Complete https://irct.ir/trial/35683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups using Permuted Block Randomization. To create a random sequence in a block randomization approach, use the website https://www.sealedenvelope.com. Also, to allocation concealment, the random sequence is assigned to a particular person. The researcher then communicates with the person according to the order of entry of the participants to the study and questions the random allocation of the participant to the specific group. For each drug (each drug box), a random number is created, defined by a number (code) and placed on the envelope, Blinding description: En In order to eliminate the bias caused by the patient's or doctor's knowledge of the received treatment type and its possible effect on the outcome of the study, the study is double blinded. Considering that the vitamin D and placebo tablets are placed in the same capsule, the patient and the assessing physician are not aware of the type of received drug. 3 Benign prostatic hypertrophy. Intervention 1: Intervention group: The intervention group includes people 50 years old and older who receive pills Vitamin D with a dose of 50000 for 6 months.This drug should be taken every two weeks. Intervention 2: The control group includes people 50 years of age and older who will receive the placebo vitamin D for 6 months. This drug should be taken every two 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 is a publishing program for study, but there is currently no decision to publish.

public Abolfazl Zendedel

Abuzar St, Ziaian Hospital, Tehran Town

Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences scientific Abolfazl Zendedel

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Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Man over 50 years old Asymptomatic or mild symptoms of benign prostatic hypertrophy based on the IPSS questionnaire. Patients with benign prostatic hypertrophy 50 years no limit Male BMI greater than 35 or pathologic weight loss (weight loss over 10% of body weight in the last 6 months) History of kidney stones, bladder and urinary tract Having prostate or bladder cancer or prostate surgery Acute or chronic prostatitis or frequent urinary tract infections• History of acute urinary retention or repeated catheters in the last three months Use of GnRH agonists, anti-androgens and any hormonal drug in the past six months, the use of herbal and non-herbal medicines to control and treat BPH The history of chronic diseases such as CVA, HTN, COPD, liver and kidney disease, and cancers .. Taking medications that affect vitamin D metabolism such as corticosteroids, phenytoin, phenobarbital, or regular use of vitamin D supplements over the past 3 months Taking diuretics such as Lasix and ... Alcohol consumption N40 Benign Prostatic Hypertrophy Treatment - Drugs Placebo Intervention group: The intervention group includes people 50 years old and older who receive pills Vitamin D with a dose of 50000 for 6 months.This drug should be taken every two weeks. The control group includes people 50 years of age and older who will receive the placebo vitamin D for 6 months. This drug should be taken every two weeks. Prostate Volume. Timepoint: At the beginning of the study and six months later. Method of measurement: sonography. Severity of clinical symptoms. Timepoint: At the beginning of the study, 3 months later, 6 months later. Method of measurement: IPSS questionnaire. PSA. Timepoint: At the beginning of the study, 3 months later, 6 months later. Method of measurement: laboratory kit. Vitamin D. Timepoint: At the beginning of the study, 3 months later, 6 months later. Method of measurement: blood test. Grant Student Thesis Approved 2018-07-21 National Ethics Committee for Biomedical Research Abuzar St, Ziaian Hospital, Tehran Town Tehran Tehran Iran (Islamic Republic of)