Determining the effect of oral vitamin D intake on the treatment of erectile dysfunction
Design
A clinical trial with a control group, with parallel groups, single blind, phase 3 on 122 patients, Sealed envelope will be used for randomization.
Settings and conduct
This study will be conducted at Urology department of Shahid Beheshti Hospital in Hamadan. The study population will be married men over 18 years of age who have erectile dysfunction and vitamin D deficiency. The study will be of single blind type, the person who evaluates the outcome of the treatment will be unaware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Erectile dysfunction; age over 18 years; serum vitamin D level less than 20 ng/ml; being married.
Exclusion criteria: Any contraindications for taking tadalafil; cardiovascular diseases; chronic headaches and migraines
Intervention groups
Intervention group: They will take a 5 mg tablet of Tadalafil along with a 1000 IU vitamin D3 tablet daily for 3 months.
Control group: They will take one 5 mg tablet of tadalafil without vitamin D3 daily for 3 months.
Main outcome variables
The main outcome will be the improvement of erectile dysfunction and the secondary outcome is an increase in serum vitamin D levels.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N34
Registration date:2024-01-23, 1402/11/03
Registration timing:prospective
Last update:2024-01-23, 1402/11/03
Update count:0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral tadalafil with and without vitamin D on the treatment of male erectile dysfunction
Public title
The effect of oral vitamin D on erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
اختلال نعوظ
Age above 18 years
being married
Serum vitamin D level less than 20 ng/ml
Exclusion criteria:
Having a contraindication for tadalafil
Having cardiovascular diseases
Chronic migraine headache
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sealed envelopes will be used for randomization. For this purpose, 122 cards will be prepared and on 62 the letter I will be written, meaning intervention, and on the other 62, the letter C will be written, meaning the control group. each will be put inside an envelope with aluminum foil and put them inside a box with their lids glued. At the time of patient arrival, one of the envelopes randomly will be selected and opened, and based on selected letter ( I or C) patients will be assigned to intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who evaluates the outcome of the treatment will be blind to the type of groups the patients belong to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Shahid Fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.UMSHA.REC.1402.621
Health conditions studied
1
Description of health condition studied
Male erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
Primary outcomes
1
Description
Erectile Function
Timepoint
Before intervention and 3 months after treatment
Method of measurement
The International Index of Erectile Function
Secondary outcomes
1
Description
Change in the serum level of vitamin D
Timepoint
Before treatment and 3 months after treatment
Method of measurement
Blood serum test
Intervention groups
1
Description
Intervention group: Consumption of Tadalafil 5 mg tablets daily along with one vitamin D3 1000 IU tablet for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Consumption of Tadalafil 5 mg tablets daily without Vitamin D for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Behzad Mohammad Souri
Street address
Eram Blvd, Ghaem Sq, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr.Behzad Mohammad Souri
Position
Urologist MD
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahid Beheshti Hospital, Eram Blvd, Ghaem Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0092
Fax
Email
Shahidbeheshti@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmide Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From Nov 2024 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document
Sending email to the scientific supervisor of the study