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
This is a clinical trial study of women with uterine myoma referred to women clinics of Alzahra and Shahid Beheshti Hospitals in Isfahan. Patients are randomly divided into two groups.A group receive vitamin D and a group placebo, that patients are blinded to type of treatment. Six months later, Sonography is done again. The sonographer has also been blinded to type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1)Patients who are willing to participate and consent to participate in the study.
2) In an ultrasound, have 1-2 uterine myoma is 20-80 millimeters
3) The serum level of vitamin D is less than 20 ng / ml
Exclusion criteria
1) Consuming hormone
2) Severe bleeding
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 2 weeks for 10 weeks. Group B patients are given a placebo.
Main outcome variables
Change the size of the myoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027998N5
Registration date:2018-01-29, 1396/11/09
Registration timing:retrospective
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-22, 1394/06/31
Expected recruitment end date
2016-09-21, 1395/06/31
Actual recruitment start date
2015-09-22, 1394/06/31
Actual recruitment end date
2016-08-21, 1395/05/31
Trial completion date
empty
Scientific title
Comparison of vitamin D and placebo supplementation in reducing uterine myoma size in women with vitamin D deficiency
Public title
Study of Vitamin D Effect on myoma size
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 1 to 2 uterine leiomyomas with size 20-80 mm
Serum levels of 25-hydroxyvitamin D3 <20 ngr/ml.
Signed a inform consent form to participate in the study
Exclusion criteria:
Consuming hormonal drugs
Massive vaginal bleeding
Age
From 35 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
72
Actual sample size reached:
69
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
Group A received vitamin D 50,000 IU every 2 weeks for 10 weeks (Iranian Zahravi Corp.), while group B received placebo with same color and shape.
Ultrasound was performed for evaluating uterine leiomyomas size with same operator who don't know about intervention and in same previous center 6 months later.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Isfahan University of Medical Sciences and Health Services
Street address
Hezar Jirib
City
ESFAHAN
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
IR.MUI.REC.1394.3.453
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
D25.9
ICD-10 code description
D25.9Leiomyoma of uterus, unspecified
Primary outcomes
1
Description
Uterine myoma size
Timepoint
Before the intervention begins and 6 months after the intervention begins
Method of measurement
X8 medison ultrasound machine
Secondary outcomes
1
Description
Serum vitamin D levels
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Radioimmunoassay
Intervention groups
1
Description
Intervention group: received vitamin D 50,000 IU every 2 weeks for 10 weeks (Iranian Zahravi Corp.)
Category
Treatment - Drugs
2
Description
Control group: Received placebo with same color and shape of vit d in intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital- Esfahan
Full name of responsible person
Maryam Ansari
Street address
Motahari
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3236 7001
Email
drm-ansari@yahoo.com
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Maryam Ansari
Street address
Soffeh
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
drm-ansari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Movahedian Attar
Street address
Hezar Jerib
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Ansari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jerib
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 3136680048031
Email
drm-ansari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sohrevardi
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 3136680048031
Email
m_hajihashemy@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3776 6578
Fax
+98 31 3236 4210
Email
m_hajihashemy@med.mui.ac.ir
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