Study of the effect of 1.25 Dihydroxy-vitamin D3 on the Th17/Treg (Cd4, FoxP3) ratio in the women with recurrent spontaneous abortion with vitamin D3 deficiency candidate for lymphocyte therapy
Study target: Study of the effect of 1.25 Dihydroxy-vitamin D3 in the women with recurrent spontaneous (RSA) abortion with immunology reasons. Study design: randomized, double blind, controled with placebo. Inclusion criteria: 1) women with RSA in age 20-45 years with possibility of immunology reasons candidate for lymphocyte therapy; 2) the women with RSA who have serum levels of vitamin D3 less than or equal 100 nmol/l; 3) having a regular menstrual cycle. Exclusion criteria: 1) having an irrigular menstrual cycle 2) women who have consumed vitamin D3 in three months ago. Sample size: 44 persons. Intervention: injection of vitamin D3 or placebo. Time of injection: with the onset of lymphocyte therapy. The primary outcome: increasing Treg and decreasing TH17.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201258820N1
Registration date:2012-03-12, 1390/12/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-12, 1390/12/22
Registrant information
Name
Mtra Rafiee
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 7331
Email address
gharagozlo@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of 1.25 Dihydroxy-vitamin D3 on the Th17/Treg (Cd4, FoxP3) ratio in the women with recurrent spontaneous abortion with vitamin D3 deficiency candidate for lymphocyte therapy
Public title
Therapeutic effects of vitamin D3 in women with recurrent spontaneous abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) women with RSA in age 20-45 years with possibility of immunology reasons candidate for lymphocyte therapy; 2) the women with RSA who have serum levels of vitamin D3 less than or equal 100 nmol/l; 3) having a regular menstrual cycle. Exclusion criteria: 1) having an irrigular menstrual cycle 2) women who have consumed vitamin D3 in three months ago.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Daneshgah avenue, Azadi square
City
Isfahan
Postal code
8174673461
Approval date
2012-02-25, 1390/12/06
Ethics committee reference number
190057
Health conditions studied
1
Description of health condition studied
recurrent spontaneous abortion with immunology reasons
ICD-10 code
O00-O08
ICD-10 code description
pregnancy with abortive outcome
Primary outcomes
1
Description
Treg
Timepoint
before intervention and 3 months of iintervention
Method of measurement
with flow cytometry by detect CD4 and FoxP3 markers
2
Description
TH17
Timepoint
before intervention 3 months of intervention
Method of measurement
with flow cytometry by detect CD4 and IL17 markers
3
Description
TH17 to Treg ratio
Timepoint
before intervention and 3 months of intervention
Method of measurement
with dividing of TH17 to Treg
4
Description
The levels of vitamin D
Timepoint
before and after intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
pregnancy outcome
Timepoint
from 3 months after the end of treatment
Method of measurement
infant birth
Intervention groups
1
Description
Intervention group: injection of vitamin D3, 300000 IU, one injection
Category
Treatment - Drugs
2
Description
Control group: injection plasebo containing solvent material of vitamin D3, one injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Novin laboratory
Full name of responsible person
Dr Abase Rezaie
Street address
Amadegah avenue, Char bagh abassi street
City
Isfahan
2
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mitra Rafiee
Street address
in front of Aseman hotel, pole felezi
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Vice chancellor for research and technology, Dr Peyman Adibi
Street address
Isfahan university of medical sciences building NO.4, Daneshgah avenue, Azadi square
City
Isfahan
Grant name
3-124400
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan university of medical sciences
Full name of responsible person
Mitra Rafiee
Position
MSC Student
Other areas of specialty/work
Street address
Department of immunology, Medical school, Isfahan university of medical sciences, Daneshgah avenue, Azadi square
City
Isfahan
Postal code
8174673548
Phone
+98 56 1444 7331
Fax
+98 913 792 2431
Email
mitra_rafiee@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr Abase Rezaei
Position
PhD
Other areas of specialty/work
Street address
Medical school, Isfahan university of medical sciences, Hezar gerib avenue
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2460
Fax
+98 31 1792 2460
Email
rezaei@mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)