This Study Is Designed To Assess The Effect Of Vitamin D Supplementation During Pregnancy On Newborns Anthropometric Indexes. This Is Interventional Study .At First 130 Pregnant Single-tone Women With Vitamin D Deficiency (<30ngr/ml) Between The 24-28 Gestational Age Without The Known History Of Renal,Liver,Parathyroid,Metabolic,Bone Diseases, Mal-absorption Or Epilepsy And Medications That Influence The Metabolism Of Vitamin D And Calcium, Diabetes Or Gestational Diabetes, HTN And Pre-eclampsia And Have Fetus Without Anomalies And Have History Of Recurrent Abortion, Are Intered.Then They Separate Into 2 Groups Randomly. Control Group Includes 55 Pregnant Women Receive Daily Multivitamin With 400 u Vitamin D, Case Group Receive Daily Multivitamin And 50000u Vitamin D Weekly In 8 Weeks.At The First Of Study All Women s Vitamin D And Calcium Level Are Measured. And Then At The Time Of Admission For Termination The Blood Samples Drawn From Mother And Cord And Their Vitamin D And Calcium Are Measured.
All Newborns Anthropometric Indexes Include Height, Weight And Head Circumference Also Measured.
Pregnant Blood Pressure And Weight Gaining Are Noticed.
The Outcome Of This Study Can Be Like These: Higher Level Of Vitamin D And Calcium In Cases s Newborns And Increase In Height,Weight And Head Circumference Than Control Group And More Wight Gaining In Mother During Pregnancy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205119491N2
Registration date:2012-08-16, 1391/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-16, 1391/05/26
Registrant information
Name
Reyhaneh Ramezaninezhad
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
rramezaninezhad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University Of Medical Sciences
Expected recruitment start date
1991-11-22, 1370/09/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Vitamin D Supplementation During Pregnancy On Newborn s Antropometric Index
Public title
The Effect Of Vitamin D On Outcome Of Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Singletone Pregnancy; Gestational Age Between 24-28 Week;BMI 19-26;Vitamin D < 30 ngr/ml
Exclusion Criteria: The Known History Of Liver,Renal, Paratyroid,Bone,Metabolic Diseeases Or Epilepsy Or Malabsorbtion. Medications That Influence The Metabolism Of Vitamin D And Calcium;Recurrent Abortion; Diabet Or Gestational Diabet, HTN Or Preeclampsia; Fetus With Anolamlies Or Polihydramnios Or Oligohydramnios Or IUGR
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
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
Qazvin University Of Medical Sciences
Street address
Bahonar Street
City
Qazvin
Postal code
Approval date
2012-03-06, 1390/12/16
Ethics committee reference number
4449
Health conditions studied
1
Description of health condition studied
vitamin D dificinecy
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
2
Description of health condition studied
Nutritional Deficiency
ICD-10 code
P00.4
ICD-10 code description
Fetus and newborn affected by maternal nutritional disorders
Primary outcomes
1
Description
newborn s hight
Timepoint
at birthtime
Method of measurement
centimeter/ strip
2
Description
newborn s weight
Timepoint
at birthtime
Method of measurement
gram,
3
Description
newborn s head circumference
Timepoint
at birthtime
Method of measurement
centimeter
Secondary outcomes
1
Description
newborn level of vitamin D
Timepoint
birthtime
Method of measurement
ngr/ml
2
Description
newborn level of calcium
Timepoint
birthtime
Method of measurement
mmol/l
3
Description
mother level of vitamin D
Timepoint
time of termination
Method of measurement
ngr/ml
4
Description
mother level of calcium
Timepoint
time of termination
Method of measurement
mmol/l
Intervention groups
1
Description
in case group: vitamin D capsule 50000 u weekly for 8 weeks from 28 gestational age and multivitamin tab include 400 u vitamin D daily till termination
Category
Treatment - Drugs
2
Description
in control group:multivitamin tab include 400 u vitamin D daily till termination
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
private office
Full name of responsible person
shabnam zahir mirdamadi
Street address
west khayam avn.chehelsotoon building
City
qhazvin
2
Recruitment center
Name of recruitment center
pastor hospital
Full name of responsible person
fatemeh lalooha
Street address
valiasr street
City
qhazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qhazvin University Of Medical Sciences
Full name of responsible person
Shamekhi
Street address
Bahonar street,Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qhazvin 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
Gynecology Department of Kosar Hospital
Full name of responsible person
Dr Fatemeh Lalooha
Position
assistan of profesore
Other areas of specialty/work
Street address
Valiasr street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
+98 28 1224 2661
Email
rramezaninezhad@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gynecology Department Of kosar Hospital
Full name of responsible person
Dr Fatemeh Lalooha
Position
assistant of profesor
Other areas of specialty/work
Street address
Valiasr street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
+98 28 1224 2661
Email
rramezaninezhad@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kosar Hospital
Full name of responsible person
Dr Shabnam Zahir Mirdamadi
Position
ob/gyn resident
Other areas of specialty/work
Street address
Vali asr street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
rramezaninezhad@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)