The aim of this study was to identify the prevalence of vitamin D deficiency in an Iranian pregnant population and to analyze the impact of implementing a screening and treatment protocol by Vitamin D3 (50000 unit supplementation) among them.
Design
This is conducted at a prenatal care clinic in Tehran, Iran. Of total 357 pregnant women, 249 patients had first trimester and 278 had third trimester vitamin D level. The final sample size of this study was 216. The screening for vitamin D deficiency was typically performed at two points throughout prenatal care: one at the initial prenatal visit and another at approximately 28 weeks’ gestation. If Vitamin D status was insufficient an additional vitamin D3 supplement of 50,000 IU of ergocalciferol was prescribed weekly for 10 weeks. Due to ethical issues, the control group without the supplementation was removed .
Settings and conduct
This study designed and conducted at a prenatal care clinic in Tehran, Iran. 357cases were identified.
Participants/Inclusion and exclusion criteria
inclusion criteria: (1) maternal age of 16 years or greater at the time of consent, (2) confirmed singleton pregnancy of less than 16 weeks’ gestation at the time of consent, (3) planned to receive ongoing prenatal care in our prenatal clinic in Tehran, (4) they had at least two measurements of vitamin D levels in the first or second trimesters and in the third trimester. Exclusion criteria included twin pregnancy, maternal immune deficiency disease, and a history of gastric bypass surgery.
Intervention groups
If Vitamin D status was insufficient an additional vitamin D3 supplement of 50,000 IU of ergocalciferol was prescribed weekly for 10 weeks.
Main outcome variables
change of vitamin D level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170714035077N3
Registration date:2018-01-29, 1396/11/09
Registration timing:registered_while_recruiting
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
tahmineh ezazi Bojnordi
Name of organization / entity
North khorasan univercity of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 1635
Email address
ezazi.t@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tahmineh Ezazi Bojnordi
Expected recruitment start date
2017-03-19, 1395/12/29
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vitamin D Status and Response to Vitamin D3 (50000 unit supplementation) in pregnant Iranian woman
Public title
The vitamin D deficiency in pregnancy: prevalence and treatments
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal age of 16 years or greater at the time of consent
Confirmed singleton pregnancy of less than 16 weeks’ gestation at the time of consent
Planned to receive ongoing prenatal care in our prenatal clinic in Tehran
They had at least two measurements of vitamin D levels in the first or second trimesters and in the third trimester
Exclusion criteria:
Twin pregnancy
Maternal immune deficiency disease
A history of gastric bypass surgery
Age
From 16 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
357
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
We have one group and intervention for everyone is the same.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Univercity of Medical Sciences
Street address
emem khomeini hospital, tohid square,Tehran, Iran
City
tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.TUMS.REC:96-02-30-35934
Health conditions studied
1
Description of health condition studied
vitamin D deficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of vitamin D
Timepoint
After 24 weeks
Method of measurement
Level in blood sample
Secondary outcomes
empty
Intervention groups
1
Description
vitamin D3 supplement of 50,000 IU of ergocalciferol was prescribed weekly for 10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
prenatal care clinic Emam Khomeini hospital in Tehran, Iran
Full name of responsible person
tahmineh ezazi Bojnordi
Street address
Emam Khomaini hospital, Tohid squer, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 2217 2614
Email
tahmine_ezazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Room 206, first floor, medical School, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6641 8466
Fax
+98 21 8896 2510
Email
s.akhond@neda.net
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Tahmine Ezazi Bojnordi
Position
OBG, MD, spesialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Khomaini hospital, Tohid squer, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 22172614
Fax
Email
ezazi.t@nkums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
tahmine ezazi bojnourdi
Position
OBG
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Khomaini hospital, Tohid squer, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 22172614
Fax
Email
ezazi.t@nkums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
tahmine ezazi Bojnourdi
Position
OBG
Latest degree
Specialist
Other areas of specialty/work
Street address
Emam Khomaini hospital, Tohid squer, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 2217 2614
Fax
Email
ezazi.t@nkums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
1398
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research or therapeutic use
Mention the name of the related institution or research center and her/his position in the center and the purpose of the data request
From where data/document is obtainable
Contact Dr. Tahmineh Ezazi by email tahmine_ezazi@yahoo.com
What processes are involved for a request to access data/document
If the request is for research purpose, it will be emailed to the requestor within one week