This study is a single blind controlled trial for comparison the effectiveness of different prescription methods of vitamin D3 on obstetric and early neonatal outcomes in pregnant women with vitamin D deficiency .At first 1600 normal pregnant women aged 18-40 years with a singleton pregnancy at fewer than 14 weeks during their first antenatal visit are selected based on randomized cluster sampling from 10 health center in Masjed Soleyman(32N). The women are tested for serum 25(OH)D after being informed about the research and its objectives and gave consent to participate. Quantification of serum 25(OH)D is perform using a commercial ELISA from Immunodiagnostic Systemdimided(IDS,Tyne/UK).After baseline serum 25(OH)D levels is measured, they are classified in 3 groups that define vitD status: A-Severe vitamin D deficiency:25(OD)D<10 ng/ml.B: Moderate vitamin D deficiency:10<25(OH)D<20 ng/ml. C:Normal vitamin D status:25(OH)D>20 ng/ml. In the second phase the participants in intervention groups( A and B groups) are divided randomly in 2 intervention groups for receiving vitD3 based on protocol. Intervention Group A1: Subjects (200) are treated with 50000IU oral vitD3 weekly for a total duration of 12 weeks and they are divided randomly into 2 intervention arms:A1,1: The termination of intervention(100). A1,2: Continuation of intervention with 50000IU vitD3 monthly until delivery(100). Group A2: Subjects (200) are treated with Intramuscular administration of 300000 IU vitD3 each 6 week for 2 doses and then they are divided randomly into 2 arms: A2, 1: The termination of intervention(100). A2, 2: Continuation of intervention with 50000IU vitD3 monthly until delivery(100). Group B1: Subjects(200) are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and they are divided randomly into 2 arms: B1,1: The termination of intervention(100).B1,2: Continuation of intervention with 50000IU vitD3 monthly until delivery(100). Group B2:Subjects(200) are treated with Intramuscular administration of 300000 IU vitD3 for 1 dose and after 6 weeks they are divided randomly into 2 arms: B2,1:The termination of intervention(100). B2,2: Continuation of intervention with 50000IU vitD3 monthly until delivery(100). In C group (Control)subjects are observed only about outcomes with no intervention. In all groups one more sample is taken from the mother and cord at the time of delivery to measure serum 25(OH)D in mothers and newborns and serum Calcium levels in neonates. At the end of the trial all groups are compared with obstetric (Preeclampsia, Gestational Diabetes, Preterm labor, Premature rupture of membranes…) and neonatal outcomes(Weight, Length and Head circumference at birth…) by statistical analysis .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102519660N1
Registration date:2015-01-22, 1393/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-01-22, 1393/11/02
Registrant information
Name
Maryam Rostami
Name of organization / entity
Shahid Beheshti MedicalUniversity School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 68 1222 5471
Email address
m_rostami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrine Research Center Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency.
Public title
Comparison the Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Pregnant women ؛ Current residence in Masjed Soleyman ؛ Gestational age: under 14 weeks ؛ Maternal age18-40 years ؛ Singleton pregnancy Exclusion: Diabetes ؛ Chronic hypertension ؛ Thyroid diseases ؛ Renal dysfunction ؛Cardiovascular diseases ؛ Current use of anticonvulsant drugs such as: Phenytoin and Carbamazepine ؛ Steroidal drugs ؛Anti cholesterol ؛ Digoxin ؛ Use of any dietary supplement containing more than 400 IU/day of vitamin D
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
800
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Beheshti Medical University
Street address
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2013-12-16, 1392/09/25
Ethics committee reference number
490-10ECRIES92/10/25
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Avitaminosis D
Primary outcomes
1
Description
Abortion
Timepoint
In intervention
Method of measurement
Yes/ No
2
Description
Preterm Lobour
Timepoint
In intervention
Method of measurement
Yes/ No
3
Description
Gestational Diabetes
Timepoint
In intervention
Method of measurement
Yes/ No
4
Description
Preeclampsia
Timepoint
In intervention
Method of measurement
Yes/ No
5
Description
Serum 25(OH)D concentration in mother
Timepoint
In intervention
Method of measurement
Ng/ml
Secondary outcomes
1
Description
Birth weigth
Timepoint
after intervention
Method of measurement
gr
2
Description
Head circumference
Timepoint
After intervention
Method of measurement
Cm
3
Description
Cord blood 25(OH)D level
Timepoint
After intervention
Method of measurement
Ng/ml
4
Description
Birth Lenght
Timepoint
After intervention
Method of measurement
Cm
5
Description
Cord blood Calcium
Timepoint
After intervention
Method of measurement
Ng/ml
6
Description
Apgar Score 1 minute and 5 minute
Timepoint
After intervention
Method of measurement
Standard Apgar Score
7
Description
Fall of umbilical cord time
Timepoint
After intervention
Method of measurement
Day
8
Description
Neonatal Ecterus
Timepoint
After intervention
Method of measurement
Mg/dl
Intervention groups
1
Description
Control group C: Subjectes are observed only about outcomes with no intervention.-9
Category
Treatment - Drugs
2
Description
6- Internention group B1,2 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and then termination of intervention(100)
Category
Treatment - Drugs
3
Description
7-Intervention group B2,1 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and after 6 weeks they recive 50000IU oral vitaminD3 monthly until delivey.
Category
Treatment - Drugs
4
Description
8-Intervention group B2,2 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and then termination of intervention(100).
Category
Treatment - Drugs
5
Description
2-Intervention group A1,2:Subjects are treatded with 50000IU oral vitaminD3 weekly for a total duration of 12 weeks and then termination of intervention(100).
Category
Treatment - Drugs
6
Description
3-Intervention groupA2,1: Subjects are treated with Intramascular administration of 300000 IU vitaninD3 each 6 week for 2 doses and then they recive 50000IU oral vitaminD3 monthly until delivery(100).
Category
Treatment - Drugs
7
Description
5- Internention group B1,1 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and they recive 50000IU oral vitaminD3 monthly until delivery(100).
Category
Treatment - Drugs
8
Description
4-Intervention groupA2,2: Subjects are treated with Intramascular administration of 300000 IU vitaminD3 each 6 week for 2 doses and then termination of intrevention(100).
Category
Treatment - Drugs
9
Description
1-Intervention group A1 ,1: Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 12 weeks and they recive 50000IU oral vitD3 monthly until delivery(100).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Reseatch Center Shahid beheshti University of Medical Sciences
Full name of responsible person
Dr Fahimeh Ramezani Tehrani
Street address
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Sciences for Research of Shahid Beheshti Medical university
Full name of responsible person
Dr Fahimeh Ramezani Tehrani
Street address
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
City
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences for Research of Shahid Beheshti Medical university
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
School of Nursing and Midwifery Shahid Beheshti Medicl University
Full name of responsible person
Maryam Rostami
Position
PhD Student of Reproductive Health
Other areas of specialty/work
Street address
No 7,Phase 1 of Farhangiam,
City
Masjed Soleyman
Postal code
Phone
+98 68 1222 5471
Fax
Email
m6326726@gmail.com؛ m_rostami@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrine Reseatch Center Shahid beheshti University of Medical Sciences
Full name of responsible person
Dr Farhad Hossein panah
Position
Chief of the endocrine DPT
Other areas of specialty/work
Street address
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
farhad.hosseinpanah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery Shahid Beheshti Medicl
Full name of responsible person
Maryam Rostami
Position
PhD Student of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery Shahid Beheshti Medicl
City
Tehran
Postal code
Phone
00
Fax
Email
m6326726@gmail.com ؛ m_rostami@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)