The aim of study is to evaluate the effects of vit D supplements on decreasing myoma size, in women who have myoma and insufficient levels of vit D .All eligible patients who have myoma and referred to Yas hospital will be entered to the study. These women need observation or treatment, after they have signed informed consent for participation to study, sonogram will be done for evaluation of the size of myoma then Vit D level is measured and according to the level of vitD ,if the level is deficient so they will be prescribed vit D 50000 weekly for treatment, and they will be excluded from study; if the level is insufficient they will be divided to both groups , one group will receive vit D supplement and the other group will be observed as control group. After 8 weeks myoma size again will be measured by sonogram .The results of the myoma size will be gathered. Randomization is done by a computed generated random numbers program . Patients and physicians are not blinded to study groups but the radiologist and lab technicians are blind regarding study groups. The sample size is 170 patients with myoma for this study. History of infertility, type of myoma, BMI, and age will be gathered and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703122576N15
Registration date:2017-07-09, 1396/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Tehran University of Medical Sciences
Expected recruitment start date
2017-04-01, 1396/01/12
Expected recruitment end date
2019-04-01, 1398/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vit D supplements on fibroid size in women who have insufficient levels and comparison by control group
Public title
Effect of vit D levels on myoma size
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All women who have myoma and referred to hospital; Level of vit D is insufficient or deficient; age 18-50 years old
Exclusion criteria: All women who have myoma and sufficient levels of vitD
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done by a computed generated random numbers program by a technician who is not blind to study
Secondary Ids
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Fifth floor, Central building of TUMS, Ghods Ave, Keshavarz Boulvard
City
Tehran
Postal code
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2701
Health conditions studied
1
Description of health condition studied
Myoma
ICD-10 code
D-25
ICD-10 code description
Myoma
Primary outcomes
1
Description
Size of myoma
Timepoint
o,8 weeks
Method of measurement
Sonogram before starting study and 8 weeks after starting treatment protocol
Secondary outcomes
1
Description
Vit D levels
Timepoint
Before study ,after 8 weeks
Method of measurement
Level of vit D before the study and 8 weeks after starting treatment protocol
Intervention groups
1
Description
Intervention group: Pearl vit D 50000 once per week for 8 weeks orally
Category
Treatment - Drugs
2
Description
Control group: No supplement of Vit D prescribed during 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Karim khan bridge, North Ostad Nejatollahi avenue, Yas Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Miss Mostofi
Street address
Fifth floor, Central building of TUMS, Ghods Ave, Keshavarz Boulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate Professor
Other areas of specialty/work
Street address
Yas hospital, North Ostad Nejatollahi, Villa street
City
Tehran
Postal code
Phone
+98 21 8880 0115
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
TUMS
Full name of responsible person
Fatemeh Davari Tanha
Position
Associate Professor
Other areas of specialty/work
Street address
Yas Hospital, North Nejatollahi, Villa Street
City
Tehran
Postal code
Phone
+98 21 8880 0115
Fax
Email
fatedavtanha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Davari Tanha
Position
Associate professor of TUMS
Other areas of specialty/work
Street address
Yas Hospital, North ostadnejatollahi avenue, Karimkhanzand bridge
City
Tehran
Postal code
Phone
+98 21 8880 0115
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)