Protocol summary
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Study aim
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The effect of vitamin D supplements on Benign prostatic hypertrophy
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Design
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Clinical trials with control group, with parallel groups, blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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The intervention group received vitamin D and the control group received placebo randomly.
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Main outcome variables
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Prostate Volume
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-09-03, 1398/06/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of vitamin D supplements on benign hypertrophy
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Public title
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The effect of vitamin D on the treatment of prostate hypertrophy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-21, 1397/04/30
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.257
Health conditions studied
1
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Description of health condition studied
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Benign prostatic hypertrophy
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ICD-10 code
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N40
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ICD-10 code description
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Benign Prostatic Hypertrophy
Primary outcomes
1
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Description
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Prostate Volume
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Timepoint
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At the beginning of the study and six months later
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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Severity of clinical symptoms
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Timepoint
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At the beginning of the study, 3 months later, 6 months later
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Method of measurement
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IPSS questionnaire
2
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Description
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PSA
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Timepoint
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At the beginning of the study, 3 months later, 6 months later
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Method of measurement
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laboratory kit
3
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Description
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Vitamin D
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Timepoint
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At the beginning of the study, 3 months later, 6 months later
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Method of measurement
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blood test
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Grant Student Thesis
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available