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Protocol summary
Participants are randomly divided into 2 groups A and B. To group A, vitamin D supplementation is provided from Iran's Zahravi factory with a dose of 50,000 units every weeks for 2 months then 1 tablet per month for another 2 months. Group B patients are given a placebo.
Participants are randomly divided into 2 groups A and B. To group A, vitamin D supplementation is provided from Iran's Zahravi factory with a dose of 50,000 units every week for 12 weeks. Group B patients are given a placebo.
Participants are randomly divided into 2 groups A and B. To group A, vitamin D supplementation is provided from Iran's Zahravi factory with a dose of 50,000 units every weeksweek for 2 months then 1 tablet per month for another 2 months12 weeks. Group B patients are given a placebo.
شرکت کنندگان به صورت تصادفی به 2 گروه A و B تقسیم می شوند. به افراد گروه A مکمل ویتامین D از کارخانه زهراوی ساخت ایران با دوزه 50000 واحد هر هفته به مدت 2 ماه و سپس ماهانه به مدت 2 ماه دیگر داده می شود. به افراد گروه B دارونما داده میشود.
شرکت کنندگان به صورت تصادفی به 2 گروه A و B تقسیم می شوند. به افراد گروه A مکمل ویتامین D از کارخانه زهراوی ساخت ایران با دوزه 50000 واحد هر هفته به مدت 12 هفته داده می شود. به افراد گروه B دارونما داده میشود.
شرکت کنندگان به صورت تصادفی به 2 گروه A و B تقسیم می شوند. به افراد گروه A مکمل ویتامین D از کارخانه زهراوی ساخت ایران با دوزه 50000 واحد هر هفته به مدت 2 ماه و سپس ماهانه به مدت 2 ماه دیگر12 هفته داده می شود. به افراد گروه B دارونما داده میشود.
General information
40
60
4060
Patients who are willing to participate and consent to participate in the study
Having 1-2 uterine myoma with 20-80 millimeters diameter according to ultrasound findings
Serum level of vitamin D less than 20 ng / ml
Patients who are willing to participate and consent to participate in the study
Having 1-3 uterine myoma with at least 10 millimeters diameter in largest myoma according to ultrasound findings
Serum level of vitamin D less than 30ng / ml
Patients who are willing to participate and consent to participate in the study Having 1-23 uterine myoma with 20-80at least 10 millimeters diameter in largest myoma according to ultrasound findings Serum level of vitamin D less than 20 ng30ng / ml
بیمارانی که تمایل به شرکت دارند و رضایت نامه شرکت در مطالعه را امضاء کرده اند
دارای 1-2 میوم رحمی به ابعاد 20-80 میلی متر بر اساس یافته های سونوگرافی
سطح سرمی ویتامین D کمتر از ngr/ml 20
بیمارانی که تمایل به شرکت دارند و رضایت نامه شرکت در مطالعه را امضاء کرده اند
دارای 1-3 میوم رحمی با قطر حداقل 10 میلیمتر در بزرگترین میوم بر اساس یافته های سونوگرافی
سطح سرمی ویتامین D کمتر از ngr/ml 30
بیمارانی که تمایل به شرکت دارند و رضایت نامه شرکت در مطالعه را امضاء کرده اند دارای 1-23 میوم رحمی به ابعاد 20-80 میلی متربا قطر حداقل 10 میلیمتر در بزرگترین میوم بر اساس یافته های سونوگرافی سطح سرمی ویتامین D کمتر از ngr/ml 2030
Consuming hormone
Severe vaginal bleeding
Consuming hormone
Severe vaginal bleeding
Planning for pregnancy
Consuming hormone Severe vaginal bleeding Planning for pregnancy
مصرف هورمون
خونریزی واژینال شدید
مصرف هورمون
خونریزی واژینال شدید
برنامه ریزی برای بارداری
مصرف هورمون خونریزی واژینال شدید برنامه ریزی برای بارداری
Intervention groups
#1
Intervention group: received vitamin D 50,000 IU every weeks for 2 months then 1 tablet of vitamin D 50,000 IU per month for 2 months (Iranian Zahravi Corp.)
Intervention group: received vitamin D 50,000 IU every week for 12 weeks (Iranian Zahravi Corp.)
Intervention group: received vitamin D 50,000 IU every weeksweek for 2 months then 1 tablet of vitamin D 50,000 IU per month for 2 months12 weeks (Iranian Zahravi Corp.)
گروه مداخله: مصرف هر هفته 1 عدد قرص ویتامین D 50,000 IU تا 2 ماه، سپس مصرف ماهانه یک قرص برای دو ماه (شرکت دارویی زهراوی)
گروه مداخله: مصرف هر هفته 1 عدد قرص ویتامین D 50,000 IU تا 12 هفته (شرکت دارویی زهراوی)
گروه مداخله: مصرف هر هفته 1 عدد قرص ویتامین D 50,000 IU تا 2 ماه، سپس مصرف ماهانه یک قرص برای دو ماه12 هفته (شرکت دارویی زهراوی)
#2
Control group: received placebo every weeks for 2 months then 1 tablet of vitamin D 50,000 IU per month for 2 months (Iranian Zahravi Corp.)
Control group: received placebo every weeks for 12 weeks (Iranian Zahravi Corp.)
Control group: received placebo every weeks for 2 months then 1 tablet of vitamin D 50,000 IU per month for 2 months12 weeks (Iranian Zahravi Corp.)
گروه کنترل: مصرف هر هفته 1 عدد قرص دارونما تا 2 ماه، سپس مصرف ماهانه یک قرص برای دو ماه (شرکت دارویی زهراوی ایران)
گروه کنترل: مصرف هر هفته 1 عدد قرص دارونما تا 12 هفته (شرکت دارویی زهراوی ایران)
گروه کنترل: مصرف هر هفته 1 عدد قرص دارونما تا 2 ماه، سپس مصرف ماهانه یک قرص برای دو ماه12 هفته (شرکت دارویی زهراوی ایران)
Recruitment centers
#1
Name of recruitment center - English: Persian Gulf Hospital of Bandar Abbas
Name of recruitment center - Persian: بیمارستان خلیج فارس بندرعباس
Full name of responsible person - English: Somayye Arzhe
Full name of responsible person - Persian: سمیه ارژه
Street address - English: Pardis Blvd,Persian Gulf Hospital
Street address - Persian: بلوار پردیس بیمارستان خلیج فارس
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7919783141
Phone: +98 76 3367 0280
Fax:
Email: dr.arzhe@hums.ac.ir
Web page address:
Name of recruitment center - English: Khaleej-e-fars Hospital of Bandar Abbas
Name of recruitment center - Persian: بیمارستان خلیج فارس بندرعباس
Full name of responsible person - English: Somayye Arzhe
Full name of responsible person - Persian: سمیه ارژه
Street address - English: Pardis Blvd,Persian Gulf Hospital
Street address - Persian: بلوار پردیس بیمارستان خلیج فارس
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7919783141
Phone: +98 76 3367 0280
Fax:
Email: dr.arzhe@hums.ac.ir
Web page address:
Name of recruitment center - English: Persian GulfKhaleej-e-fars Hospital of Bandar Abbas Name of recruitment center - Persian: بیمارستان خلیج فارس بندرعباس Full name of responsible person - English: Somayye Arzhe Full name of responsible person - Persian: سمیه ارژه Street address - English: Pardis Blvd,Persian Gulf Hospital Street address - Persian: بلوار پردیس بیمارستان خلیج فارس City - English: Bandar Abbas City - Persian: بندرعباس Province: Hormozgan Country: Iran (Islamic Republic of) Postal code: 7919783141 Phone: +98 76 3367 0280 Fax: Email: dr.arzhe@hums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Somayye Arzhe
Full name of responsible person - Persian: سمیه ارژه
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No.103, Eisar2 Alley, Eisar Ave
Street address - Persian: خیابان ایثار،کوچه ایثار 2 ،مجتمع محترم 4،واحد 103
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7915879837
Phone: +98 76 3362 4314
Mobile: +98 917 362 5310
Fax:
Email: mohammadsomayye@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Darsareh
Full name of responsible person - Persian: فاطمه درساره
Position - English: Midwife
Position - Persian: ماما
Latest degree: phd
Area of specialty/work: 49
Area of specialty/work title - English: Midwifery
Area of specialty/work title - Persian: مامایی
Street address - English: Bagh Aonir st. Amir Abad
Street address - Persian: باغ منیر، امیر آباد
City - English: Bandar Abbas
City - Persian: بندر عباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7918796758
Phone: +98 67 3355 4515
Mobile: +98 917 363 8430
Fax:
Email: famadarsareh@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Somayye ArzheFatemeh Darsareh Full name of responsible person - Persian: سمیه ارژهفاطمه درساره Position - English: ResidentMidwife Position - Persian: رزیدنتماما Latest degree: med_doctorphd Area of specialty/work: 49 Area of specialty/work title - English: Midwifery Area of specialty/work title - Persian: مامایی Street address - English: No.103, Eisar2 Alley, Eisar AveBagh Aonir st. Amir Abad Street address - Persian: خیابان ایثارباغ منیر،کوچه ایثار 2 ،مجتمع محترم 4،واحد 103 امیر آباد City - English: Bandar Abbas City - Persian: بندرعباسبندر عباس Province: Hormozgan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 79158798377918796758 Phone: +98 76 3362 431467 3355 4515 Mobile: +98 917 362 5310363 8430 Fax: Email: mohammadsomayyefamadarsareh@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
Determine the effectiveness of vitamin D supplements in reducing uterine myoma size in women with vitamin D deficiency
Design
Clinical trials with drug and placebo control group, treatment-based, with parallel groups, blind, randomized by block
Settings and conduct
A clinical trial study on women with uterine myoma referred to women clinics of Khaleej-e-fars Hospital in Bandar Abbas. Patients are randomly divided into two groups. One group receive vitamin D and the other group will receive placebo. All participants are blinded to type of treatment. 4 months later, Sonography is done again. The sonographer has also been blinded to type of treatment.
Participants/Inclusion and exclusion criteria
Women with uterine myoma with a lack of vitamin D levels who were referred to women clinics of Khaleej-e-fars Hospital in Bandar Abbas
Intervention groups
Participants are randomly divided into 2 groups A and B. To group A, vitamin D supplementation is provided from Iran's Zahravi factory with a dose of 50,000 units every week for 12 weeks. Group B patients are given a placebo.
Main outcome variables
Change in the size of the myoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040046N1
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2019-07-28, 1398/05/06
Update count:1
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Somayye Arzhe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3362 4314
Email address
dr.arzhe@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on uterine myoma of women attending to hospital
Public title
The effect of vitamin D supplementation on uterine myoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are willing to participate and consent to participate in the study
Having 1-3 uterine myoma with at least 10 millimeters diameter in largest myoma according to ultrasound findings
Serum level of vitamin D less than 30ng / ml
Exclusion criteria:
Consuming hormone
Severe vaginal bleeding
Planning for pregnancy
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
all eligible patients before intervention were randomly divided into two groups using a block randomization procedure
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness will be that the supplementation of vitamin D and placebo will not be communicated to anyone by someone outside the research team and team members such as a clinical care provider, and supplementary participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Shahid Mohammadi hospital in Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.HUMS.REC.1397.045
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, unspecified D25.9
Primary outcomes
1
Description
Size of uterine myoma
Timepoint
Before intervention and 4 months after intervention
Method of measurement
sonography
Secondary outcomes
1
Description
Serum vitamin D levels
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Radioimmunoassay
Intervention groups
1
Description
Intervention group: received vitamin D 50,000 IU every week for 12 weeks (Iranian Zahravi Corp.)
Category
Treatment - Drugs
2
Description
Control group: received placebo every weeks for 12 weeks (Iranian Zahravi Corp.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khaleej-e-fars Hospital of Bandar Abbas
Full name of responsible person
Somayye Arzhe
Street address
Pardis Blvd,Persian Gulf Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0280
Email
dr.arzhe@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Street address
saheli Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6368
Email
mail@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bagh Aonir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 67 3355 4515
Fax
Email
famadarsareh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Somayye Arzhe
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.103, Eisar2 Alley, Eisar Ave
City
Bandar Abbas
Province
Hormozgan
Postal code
7915879837
Phone
+98 76 3362 4314
Fax
Email
mohammadsomayye@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Somayye Arzhe
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.103, Eisar2 Alley, Eisar Ave
City
Bandar Abbas
Province
Hormozgan
Postal code
7915879837
Phone
+98 76 3362 4314
Fax
Email
mohammadsomayye@gmail.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
Yes - There is 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
Title and more details about the data/document
No more information
When the data will become available and for how long
No more information
To whom data/document is available
No more information
Under which criteria data/document could be used
No more information
From where data/document is obtainable
No more information
What processes are involved for a request to access data/document