Determination of the effect of vit D supplementation on fetal anthropometric parameters
Design
In this research 130 patients referring to perinatal clinic were chosen. After informed consent and posture pregnancy test, concomitant with first trimester routine test, Blood sample would be freezed at -80 to determination Vit D level after finishing the research. Then patients were randomly divided into two control & intervention groups by SPSS & code was allocated to each one of them.
Settings and conduct
After random division into case and control group , The intervention group also receives routine gestational medications such as calcium and 1000 unit of vitamin D per day. At 12, 19, and 34, ultrasound is used to measure variables.Then the level of vitamin D in the frozen sample is checked for all patients. They are interpreted in terms of results are classified in three group deficiency, insufficiency, sufficient in terms of vitamin D levels. The patient, a statistician and a sonologist will be unaware of all the results until the final conclusion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian race; Healthy appearance; No history of chronic disease; Normal body mass; non smoker
Exclusion criteria: Abortion; Intrauterine fetal death; multi fetal pregnancy
pregnancy with abnormal fetus
Intervention groups
The control group received routine pregnancy care including calcium and case group received 1000 unit of vitamin D per day.
Main outcome variables
Fetal anthropometric parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140317017034N6
Registration date:2018-06-25, 1397/04/04
Registration timing:retrospective
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Homeira Vafaei Cisakht
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
vafaeih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D supplementation on fetal antropometric parameters in pregnant ladies
Public title
Effect of Vitamin D in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race
Healthy appearance
No history of chronic disease
Normal body mass
non smoker
Exclusion criteria:
Abortion
Intrauterine fetal death
Multiple pregnancy
pregnancy with abnormal fetus
Age
From 20 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Using Permutation block method, they are divided into control and intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2017-10-21, 1396/07/29
Ethics committee reference number
IR.SUMS.MED.REC.1396.78
Health conditions studied
1
Description of health condition studied
Supplements in pregnancy
ICD-10 code
F51.0
ICD-10 code description
maternal disorders predominantly related to pregnancy
Primary outcomes
1
Description
Femur length
Timepoint
12th, 19th and 34th weeks of pregnancy
Method of measurement
Ultrasound machine
2
Description
CRL
Timepoint
12th, 19th and 34th weeks of pregnancy
Method of measurement
Ultrasound machine
3
Description
PMD, MSD, HL , fetal weigth
Timepoint
12th, 19th and 34th weeks of pregnancy
Method of measurement
Ultrasound machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vit D 1000 unit per day until delivery.
Category
Treatment - Other
2
Description
Control group: Routine pregnancy care including calcium
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Namazi
Street address
Shahid Chamran blvd, Hafez Clinic
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
hafez_perina@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University Of medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Namazi
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
hafez_perina@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Homeira Vafaei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
vafaeih@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Bazrafshan
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Laboratory Medicine
Street address
Maternal-fetal medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
bazrafshan.kh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2018 Ethic form: 2018
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
n IPD: Vice chancellery Ethic form: Vice chancellery