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Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shapor MansourSamaee
Full name of responsible person - Persian: شاپور منصورسمایی
Position - English: resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 28
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Abuzar St, Ziaian Hospital, Tehran Town
Street address - Persian: خیابان ابوذر، بیمارستان ضیائیان، شهر تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1366736511
Phone: +98 21 5517 6031
Mobile: +98 912 261 3800
Fax:
Email: s.masamaei@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shapour Mansoursamaei
Full name of responsible person - Persian: شاپور منصورسمایی
Position - English: resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 28
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Abuzar St, Ziaian Hospital, Tehran Town
Street address - Persian: خیابان ابوذر، بیمارستان ضیائیان، شهر تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1366736511
Phone: +98 21 5517 6031
Mobile: +98 912 261 3800
Fax:
Email: s.masamaei@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Shapor MansourSamaeeShapour Mansoursamaei Full name of responsible person - Persian: شاپور منصورسمایی Position - English: resident Position - Persian: رزیدنت Latest degree: med_doctor Area of specialty/work: 28 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Abuzar St, Ziaian Hospital, Tehran Town Street address - Persian: خیابان ابوذر، بیمارستان ضیائیان، شهر تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1366736511 Phone: +98 21 5517 6031 Mobile: +98 912 261 3800 Fax: Email: s.masamaei@yahoo.com Web page address:
Protocol summary
Study aim
The effect of vitamin D supplements on Benign prostatic hypertrophy
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
At Ziaiean Hospital, men who are over 50 are eligible to enter the study.
First, vitamin D supplementation (50,000 units) is given every two weeks and the placebo is given to control group for 6 months.
After the completion of the course, sonography is performed for intervention and control patients .
After the completion of the course, the plan is again performed for patients with ultrasound intervention and control.
Participants/Inclusion and exclusion criteria
Man over 50 years old ,Asymptomatic or mild symptoms Benign prostatic hypertrophy based on the IPSS questionnaire, Patients with benign prostatic hypertrophy
Exit criteria :History of kidney stones, bladder and urinary tract stones, Having prostate or bladder cancer or prostate surgery, Use of GnRH agonists, anti-androgens and any hormonal drug in the past six months.
Intervention groups
The intervention group received vitamin D and the control group received placebo randomly.
Main outcome variables
Prostate Volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041089N3
Registration date:2019-09-03, 1398/06/12
Registration timing:registered_while_recruiting
Last update:2020-09-05, 1399/06/15
Update count:1
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Abolfazl Zendehdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5517 6031
Email address
azendedel@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplements on benign hypertrophy
Public title
The effect of vitamin D on the treatment of prostate hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Man over 50 years old
Asymptomatic or mild symptoms of benign prostatic hypertrophy based on the IPSS questionnaire.
Patients with benign prostatic hypertrophy
Exclusion criteria:
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
Age
From 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.257
Health conditions studied
1
Description of health condition studied
Benign prostatic hypertrophy
ICD-10 code
N40
ICD-10 code description
Benign Prostatic Hypertrophy
Primary outcomes
1
Description
Prostate Volume
Timepoint
At the beginning of the study and six months later
Method of measurement
sonography
Secondary outcomes
1
Description
Severity of clinical symptoms
Timepoint
At the beginning of the study, 3 months later, 6 months later
Method of measurement
IPSS questionnaire
2
Description
PSA
Timepoint
At the beginning of the study, 3 months later, 6 months later
Method of measurement
laboratory kit
3
Description
Vitamin D
Timepoint
At the beginning of the study, 3 months later, 6 months later
Method of measurement
blood test
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Mansour ShaporSamaee
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
s.masamaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeeian
Street address
Keshavarz Blvd - Qods St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6130
Email
research-zia@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Grant Student Thesis
Proportion provided by this source
10
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
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Zendedel
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
azendedel@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Zendedel
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
-
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
azendedel@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shapour Mansoursamaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
s.masamaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available