Determining the effect of vitamin D intake on changes in biochemical levels related to prostate size in patients with benign prostatic hyperplasia.
Design
Clinical trial with control group, factorial, double-blind, randomized, phase 4 on 60 patients. Randomization using Excel software.
Settings and conduct
People referring to the urologist of Samen Al-Aimeh Hospital in Mashhad.
The researcher is blind and the colleague will assist the patients in designing the study.
Participants/Inclusion and exclusion criteria
suffered from BPH based on the diagnosis of a clinical specialist
Signing a informed consent form
No entry:
History of prostate cancer
Intervention groups
The group receiving vitamin D soft gel 5000 units once a week for 8 weeks.
Main outcome variables
Serum levels of vitamin D.
Serum levels of calcium and phosphorus
Serum levels of Testosterone and LH
Serum PSA levels
Prostate size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038585N9
Registration date:2020-11-02, 1399/08/12
Registration timing:registered_while_recruiting
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
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
Effect of vitamin D on biochemical indicators and clinical symptoms in military personnel with benign prostatic hyperplasia
Public title
Effect of vitamin D on prostate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffered from BPH based on the diagnosis of a clinical specialist
Signing of a informed consent form
Exclusion criteria:
Allergy to vitamin D
Age
No age limit
Gender
Male
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by block randomization method. Random sequence generation was done using table of random numbers by a third trained person. Allocation concealment was performed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Vitamin d and its placebos will manufactured by Abureyhan company. All Vitamin d and its placebo will provided by Abureyhan company in prepacked boxes numbered for each patient according to the randomization sequence. Vitamin d and its placebos will in the same form of package and the patients and researcher will not aware of the content of the pack until the end of trial
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Tehran, Vanak Square, Mulla Sadra St., South Sheikh Baha'i St.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.BMSU.REC.1399.300
Health conditions studied
1
Description of health condition studied
benign prostatic hyperplasia
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Serum levels of prostate-specific antigen (PSA)
Timepoint
At the beginning of the study and 56 days after weekly intake of vitamin D.
Method of measurement
Using a specific kit
Secondary outcomes
1
Description
serum levels of vitamin d
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
with using specific kit
2
Description
serum levels of calcium and phosphorus
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
with using specific kit
3
Description
Serum levels of testosterone and LH
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
with using specific kit
4
Description
size of prostate
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
with using sonogrphy
5
Description
Clinical signs of prostate hyperplasia
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
Using a validated questionnaire
Intervention groups
1
Description
Intervention group:There are 30 people in this group who are studied once a week for 8 weeks using a vitamin D supplement containing 50,000 international units of D3. Drugs and placebo are purchased from Abureihan Pharmaceutical Company.
Category
Prevention
2
Description
Control group: The "control group" uses the same placebo as the vitamin D supplement. In the control group, one placebo will be taken weekly for 8 weeks.Drugs and placebo are purchased from Abureihan Pharmaceutical Company.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Samen Al-Aimeh Hospital, Mashhad
Full name of responsible person
Reza Azarian moghaddam
Street address
57 Imam Khomeini Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9157451210
Phone
+98 51 3622 3838
Email
samen@gamil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim parastouei
Street address
South Sheikh Baha'i St. Mulla Sadra St, Vanak Square.
City
Tehran
Province
Tehran
Postal code
912700255
Phone
+98 21 8804 0060
Email
parasstouei@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran, Vanak Square, Mulla Sadra St., South Sheikh Baha'i St.
City
Tehran
Province
Tehran
Postal code
9125007002
Phone
+98 21 8248 3516
Email
parastouei@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
+98 21 8804 0060
Email
parastouei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
+98 21 8804 0060
Email
parastouei@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after identifying individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Statistical analysis is allowed on the documents and can be used after the data is published.
From where data/document is obtainable
Email the project executor.
parastouei@bmsu.ac.ir
What processes are involved for a request to access data/document
After receiving the email, the documents will be sent to the person within a maximum of one week.