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IRCT20180930041188N1 IRCT 2019-02-03 Mashhad University of Medical Sciences The effectiveness of vitamin D deficiency in the treatment of patients with erectile dysfunction The effectiveness of vitamin D deficiency in the treatment of patients with erectile dysfunction 2019-04-21 anticipated 40 Complete https://irct.ir/trial/37074 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this purposive sampling, Subjects are divided into two groups of intervention and control by simple randomization and table of random numbers. In order to hide the random assignment, the method of sealed envelopes is used which the type of treatment for each patient is written in tabs as a code (odd and even numbers). Each code will placed in sealed envelopes and once a patient enters the study, physician take an envelope respectively and notes the patient's name and contact number, Blinding description: This is a triple blind study. Physician take an envelope, respectively which is blind to the patient's assigned group. According to the assigned number (odd or even numbers), the relevant drug of its therapeutic line is given to the patient. The researcher records the delivered drug code. Patients are also unaware of their treatment group. After completion of the treatment and collecting the data, the analyzer analyzes the data based on their code (odd or even). Evaluators and analyzer will be unaware of the intervention and control groups. 3 Erectile dysfunction. Intervention 1: Intervention group: patients receive routine Tadalafil with a dose of 20 mg and vitamin D supplement (Perl 50000 units of vitamin D per week for 10 weeks). Intervention 2: Control group: patients receive routine Tadalafil with a dose of 20 mg and placebo. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Naeimeh Farhangnezhad
Imam Reza Hospital, Imam Reza Square, Ebn_e_Sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5603 Farhangnn911@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Akhavan Rezayat
Ghaem hospital, Ahmad Abad Avenue
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2857 AkhavanRA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Erectile dysfunction (ED) Patients with vitamin D deficiency with a serum level of vitamin D 10-30 nano gram/deciliter (ng/dl) Patients satisfaction no limit no limit Male Consumers of vitamin D supplementation over the past 6 months Patients that have ED due to trauma Having neurogenic diseases like Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS) N48 Other disorders of penis Treatment - Drugs Treatment - Drugs Intervention group: patients receive routine Tadalafil with a dose of 20 mg and vitamin D supplement (Perl 50000 units of vitamin D per week for 10 weeks). Control group: patients receive routine Tadalafil with a dose of 20 mg and placebo Measuring the severity of erectile dysfunction. Timepoint: At the beginning and after the completion of the study (10 weeks after the administration of vitamin D supplementation). Method of measurement: The international index of erectile function questionnaire. Mashhad University of Medical Sciences Approved 2018-12-18 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)