This study is a Randomized clinical trial conducted on 440 pregnant women who referred to pregnancy clinic of Shahid Sadoughi and Mojibian parathyroid Hospitals.
The study population were randomly divided in two groups. Case group received 50000 IU of Vitamin D every 2 weeks and control group received 200 IU vitamin D3 daily. Blood samples were taken after 8 hours fasting. After serum extraction, samples were stored at _70 C until collection of all samples to measurement of serum 25-OHD. For all pregnant women screening for diabetes with a 75 gr oral glucose tolerance test and in 0, 1 & 2 hours (GTT) were done, Subjects with plasma glucose concentrations of one or more than 92 in 0, 180 in 1 & 153 in 2 hours were assumed positive for gestational diabettes. Inclusion criteria: all pregnant women came to prenatal clinic of Shahid Sadoughi and Mojibian Hospitals during first trimester with no history of corticosteroids or anticonvulsants use during the last 6 months were involved after blood sample taken for measurement of vitamin D serum level and were randomly assigned to two groups
Exclusion criteria any person with history of thyroid or parathyroid diseases, receiving vitamin D more than maintenance dose during last 6 months, treated with corticosteroids or anticonvulsants and history of diabetes mellitus before pregnancy.
General information
Acronym
GDM
IRCT registration information
IRCT registration number:IRCT201107237097N1
Registration date:2012-02-27, 1390/12/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Mahdiyeh Mojibian
Name of organization / entity
Obstetric and Gynecology department
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4000
Email address
m.mojibian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi Yazd University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 50000 IU Vitamin D supplement administered two weekly on neonatal and pregnant women outcome
Public title
The effect of 50000 IU Vitamin D supplement administered two weekly on gestational Diabetes Melitus
Purpose
Prevention
Inclusion/Exclusion criteria
All pregnant women who came to prenatal clinic of Shahid Sadoughi and Mojibian Hospitals during first trimester with no history of corticosteroids or anticonvulsants use during the last 3 months were included. Exclusion criteria: history of thyroid or parathyroid diseases; receiving vitamin D more than maintenance dose during the last 6 months; treatment with corticosteroids or anticonvulsants and history of diabetes mellitus before pregnancy.
Age
From 15 years old to 48 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
440
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadughi Yazd University of Medical Sciences
Street address
Bahonar SQ - Yazd
City
Yazd
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
39312
Health conditions studied
1
Description of health condition studied
Gestational DM
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus NOS
2
Description of health condition studied
VitD deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
Vit D
Timepoint
First trimester
Method of measurement
Blood sample test
Secondary outcomes
1
Description
Gestational DM
Timepoint
First trimester
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: vitamin D supplement, 50000u tab, every 2 weeks
Category
Prevention
2
Description
Control group: vitamin D Supplement, Calcium-D tablet, 200 IU daily
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaipour Clinic
Full name of responsible person
Mrs Naghshin
Street address
City
Yazd
2
Recruitment center
Name of recruitment center
Gynecology Clinic of Mojibian Hospital
Full name of responsible person
Dr Maryam Jannati Moghaddam
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadughi Yazd University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Bahonar sq.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughi Yazd 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
Dr Mojibian hospital
Full name of responsible person
Dr Maryam Jannati Moghadam
Position
GP
Other areas of specialty/work
Street address
Ayatollah kashani ST
City
yazd
Postal code
8915635843
Phone
+98 35 1624 0061
Fax
+98 35 1623 2599
Email
m_janaty_m@yahoo.com
Web page address
www.drmojibian.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi Univercity of Medical Sceince- Yazs diabetics research center