The effectiveness of vitamin D deficiency in the treatment of patients with erectile dysfunction
Design
A three blind parallel randomized clinical trial with a control group performed on 40 patients.
Settings and conduct
In this study ED patients that refer to Ghaem and Emam Reza hospitals of Mashhad will be evaluated. Patients with serum level of vitamin D 10-30 ng/dl are enrolled to the study and are scored according to International index erectile function (IIEF) questionnaire. They are randomly assigned to either intervention or control group and after 10 weeks, the erection status is re-evaluated through the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Erectile dysfunction (ED) patients with serum level of vitamin D 10-30 ng/dl, patient satisfaction
Exclusion criteria: 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)
Intervention groups
Intervention group: Routine Tadalafil with a dose of 20 mg and vitamin D supplement (Perl 50000 units of vitamin D per week for 10 weeks) is prescribed.
Control group: Routine Tadalafil with a dose of 20 mg and placebo is prescribed.
Main outcome variables
Measuring the severity of erectile dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180930041188N1
Registration date:2019-02-03, 1397/11/14
Registration timing:prospective
Last update:2019-02-03, 1397/11/14
Update count:0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Naeimeh Farhangnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
farhangnn911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of vitamin D deficiency in the treatment of patients with erectile dysfunction
Public title
The effectiveness of vitamin D deficiency in the treatment of patients with erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Erectile dysfunction (ED) Patients with vitamin D deficiency with a serum level of vitamin D 10-30 nano gram/deciliter (ng/dl)
Patients satisfaction
Exclusion criteria:
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)
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.566
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N48
ICD-10 code description
Other disorders of penis
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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).
Category
Treatment - Drugs
2
Description
Control group: patients receive routine Tadalafil with a dose of 20 mg and placebo