Effects of vitamin D supplement during pregnancy on umbilical cord vitamin D, bone mineral density and anthropometric measurements from birth to two months later
The objective of the study is to investigate the effects of vitamin D supplementation during pregnancy on umbilical cord vitamin D, bone mineral density and anthropometric measurements from birth to two months later. Pregnant women at 26 to 28 weeks of gestation, having a singleton and alive fetus, healthy and without medical history, free of any complication of pregnancy and no previous cesarean section are invited to participate in this study. The intervention group are given 2000 IU of vitamin D3 daily as tablet until the end of pregnancy, while the control group receive placebo until delivery time. If a participant receive vitamin D supplementation or placebo less than 8 weeks, her newborn will be excluded from the study. After birth cord blood sample for 25-hydroxy vitamin D concentration is collected in the participants as far as possible. Weight, head circumference and height of the newborn are measured at birth, 4 and 8 weeks after birth. Infant bone mineral density is measured by dual-energy X-ray absorptiometry up two months after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040910327N13
Registration date:2015-07-21, 1394/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Scienses
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplement during pregnancy on umbilical cord vitamin D, bone mineral density and anthropometric measurements from birth to two months later
Public title
Effects of vitamin D supplement during pregnancy on umbilical cord vitamin D, bone mineral density and anthropometric measurements from birth to two months later
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; aged 18 years or older; at 26- 28 weeks gestation based on ultrasound; alive and singleton fetus; without a history of cesarean section; without a history of any disease; free of complication in present pregnancy; Exclusion criteria: cancellation of continuing the cooperation by the participants; taking vitamin D supplements less than 8 weeks ; nonhealthy newborn; newborn with any gross anomally
Age
To 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Allocation of the participant into the intervention or control group will be performed through block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Science Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.REC.1394.6
Health conditions studied
1
Description of health condition studied
Bone donsitometry
ICD-10 code
E35.8
ICD-10 code description
Disorders of other endocrine glands in diseases classified elsewhere
Primary outcomes
1
Description
blood cord vit D concentration
Timepoint
After Delivery
Method of measurement
ELISA or another avialable method
2
Description
Bone densitometry
Timepoint
during first two months after birth
Method of measurement
Radiology and DXA method
3
Description
Antropometric measurments (height, weight and head circumference)
Timepoint
At birth, at 4 and 8 weeks later
Method of measurement
Metric system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2000 IU of vitamin D3 from 26-28
weeks gestation daily until delivery
Category
Prevention
2
Description
control group: placebo from 26-28 weeks gestation daily
until delivery or routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Farideh Vaziri
Street address
Chamran boulevard
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univercity of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univercity 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
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4253
Fax
Email
vazirif@sums.ac.ir; roose82003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Hossein Dabaghmanesh
Position
Medical Doctor, Faculty member
Other areas of specialty/work
Street address
Zans street
City
Shiraz
Postal code
Phone
+98 71 3647 4253
Fax
Email
vazirif@sums.ac.ir; roose82003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)