Protocol summary
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Study aim
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Determine the effectiveness of vitamin D supplements in reducing uterine myoma size in women with vitamin D deficiency
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Design
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Clinical trials with drug and placebo control group, treatment-based, with parallel groups, blind, randomized by block
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Change in the size of the myoma
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:
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
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Registration date
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2018-08-29, 1397/06/07
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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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2017-03-21, 1396/01/01
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Expected recruitment end date
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2019-03-20, 1397/12/29
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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 supplementation on uterine myoma of women attending to hospital
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Public title
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The effect of vitamin D supplementation on uterine myoma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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all eligible patients before intervention were randomly divided into two groups using a block randomization procedure
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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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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2018-05-29, 1397/03/08
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Ethics committee reference number
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IR.HUMS.REC.1397.045
Health conditions studied
1
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Description of health condition studied
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Uterine myoma
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ICD-10 code
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D25.9
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ICD-10 code description
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Leiomyoma of uterus, unspecified D25.9
Primary outcomes
1
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Description
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Size of uterine myoma
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Timepoint
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Before intervention and 4 months after intervention
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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Serum vitamin D levels
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Timepoint
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Before intervention and 4 months after intervention
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Method of measurement
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Radioimmunoassay
Intervention groups
1
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Description
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Intervention group: received vitamin D 50,000 IU every week for 12 weeks (Iranian Zahravi Corp.)
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Category
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Treatment - Drugs
2
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Description
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Control group: received placebo every weeks for 12 weeks (Iranian Zahravi Corp.)
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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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Yes
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Title of funding source
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Bandare-abbas University of Medical Sciences
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Proportion provided by this source
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100
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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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Yes - There is 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
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Title and more details about the data/document
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No more information
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When the data will become available and for how long
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No more information
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To whom data/document is available
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No more information
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Under which criteria data/document could be used
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No more information
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From where data/document is obtainable
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No more information
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What processes are involved for a request to access data/document
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No more information
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Comments
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