The objective of the study is to investigate the effects of vitamin D supplementation during pregnancy on functional thyroid tests like TSH, Free T4, Anti TPO antibody, Anti TG antibody. Pregnant women at 26 to 28 weeks of gestation, having a singleton and alive fetus, healthy and without medical history, free of any complication of pregnancy and no previous cesarean section are invited to participate in this study. The intervention group are given 2000 IU of vitamin D3 daily as tablet until the end of pregnancy, while the control group receive placebo until delivery time. If a participant receive vitamin D supplementation or placebo less than 8 weeks, she will be excluded from the study. Blood samples will be collected for the abovementioned thyroid tests before intervention and during first 24 hours after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508091312N2
Registration date:2015-09-02, 1394/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-02, 1394/06/11
Registrant information
Name
Mohammad Hossein Dabbaghmanesh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 8728
Email address
dabbaghm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on thyroid function tests in pregnant women
Public title
Effects of vitamin D supplementation on thyroid function tests in pregnant women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; aged 18 years or older; at 26- 28 weeks gestation based on ultrasound; alive and singleton fetus; without a history of cesarean section; without a history of any disease; free of complication in present pregnancy; Exclusion criteria: cancellation of continuing the cooperation by the participants; taking vitamin D supplements less than 8 weeks
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.SUMS.REC.1394.87
Health conditions studied
1
Description of health condition studied
Variation in thyroid tests in pregnancy
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis
Primary outcomes
1
Description
TSH level
Timepoint
Befor intervention and first 24 hours after birth
Method of measurement
ELISA
2
Description
T4 level
Timepoint
Befor intervention and first 24 hours after birth
Method of measurement
ELISA
3
Description
Anti TPO antibody
Timepoint
Befor intervention and first 24 hours after birth
Method of measurement
ELISA
4
Description
Anti TG antibody level
Timepoint
Befor intervention and first 24 hours after birth
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2000 IU of vitamin D3 from 26-28 weeks gestation daily until delivery
Category
Treatment - Drugs
2
Description
control group: placebo from 26-28 weeks gestation daily until delivery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Farideh Vaziri
Street address
Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univercity of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univercity 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossien Dabbaghmanesh
Position
Medical Doctor,Endocrinologist, Faculty member
Other areas of specialty/work
Street address
Zans street
City
Shiraz
Postal code
Phone
+98 71 3647 4253
Fax
Email
dabbaghm@sums.ac.ir; dabbagh2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Dabaghmanesh
Position
Medical Doctor, Endocrinologist, Faculty member
Other areas of specialty/work
Street address
Zans street
City
Shiraz
Postal code
Phone
+98 71 3647 4253
Fax
Email
dabbaghm@sums.ac.ir; dabbagh2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Faculty member
Other areas of specialty/work
Street address
Zand street
City
Shiraz
Postal code
Phone
+98 36672254
Fax
Email
roose82003@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)