Objective: To determine the effect of vitamin D3 supplementation on pregnancy outcomes
Study design: one blind randomized.
Study population: this study is a randomized single blind controlled clinical trial undertaken on 460 pregnant women between 20-40 ages who refereed to women clinic of shariati Hospital of Bandarabas , Iran from 2015-2016.
Inclusion criteria: Gestational age less than 10 weeks of gestation; with no history of diabetes; hypertension; a history of polycystic ovary syndrome; lack of family history of diabetes in first-degree relatives; no family history of high blood pressure in first-degree relatives; tend the sick; the vitamin D <30ng / L in patients 10-6 weeks of pregnancy; body mass index between 19-26; lack of vitamin D during the last 6 months; singleton pregnancy; gestational first to third; Iran.
Exclusion criteria: Unwillingness to participate in the study.
Sample size: 460.
Intervention: In intervention group is used vitamin D3 1000unit oral daily since 16weeks until the end of pregnancy. They also prescribed as routine prenatal care multi vitamin that has 400unit Vitamin D-ca since 16 weeks of pregnancy. The control group is used multi vitamin that has 400unit Vitamin D daily until the end of pregnancy.
Time intervention: From 16 weeks gestation until the end of pregnancy
Primary outcomes: Vitamin D concentration in the serum, diabetes, preeclampsia, preterm delivery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121430612N2
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Najmehsadat Mosalanejad
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
mosalanejad@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of vitamin D and calcium plus vitamin D on pregnancy outcomes in pregnant women
Public title
The effect of vitamin D3 supplement on pregnancy outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age less than 10 weeks of gestation; with no history of diabetes; hypertension; a history of polycystic ovary syndrome; lack of family history of diabetes in first-degree relatives; no family history of high blood pressure in first-degree relatives; tend the sick; the vitamin D <30ng / L in patients 10-6 weeks of pregnancy; body mass index between 19-26; lack of vitamin D during the last 6 months; singleton pregnancy; gestational first to third; Iran.
Exclusion criteria: Unwillingness to participate in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
460
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
Hormozgan University of Medical Sciences
Street address
No. 7916839319, Vice chancellor for research, Shahid Mohammadi Hospital, Bandarabbas
City
Bandarabbas
Postal code
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
HUMS.REC.1395.029
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Vitamin D concentration in serum of pregnant women
Timepoint
Third trimester of pregnancy
Method of measurement
Blood exam
Secondary outcomes
1
Description
Diabete
Timepoint
since 16weeks until the end of pregnancy
Method of measurement
The record information of pregnant women
2
Description
Preeclamsia
Timepoint
since 16weeks until the end of pregnancy
Method of measurement
The record information of pregnant women
3
Description
Preterm delivery
Timepoint
since 16weeks until the end of pregnancy
Method of measurement
The record information of pregnant women
Intervention groups
1
Description
Control group: Ca-D supplement contains 400 UI vitamin D daily from 16 weeks until the end of the pregnancy was received.
Category
Prevention
2
Description
Intervention group: Vitamin D3 daily, oral 1000UI from 16 weeks until the end of the pregnancy is used. Also, this group according to routine prenatal care, ca-D supplement contains 400 UI vitamin D daily from 16 weeks until the end of the pregnancy was received.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Women Clinic of Shariati Hospital
Full name of responsible person
Dr Najmehsadat Mosalanejad
Street address
City
Bandarabbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Teymor Aghamolaei
Street address
No. 7916839319, Vice chancellor for research, Shahid Mohammadi Hospital, Bandarabbas
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Najmehsadat Mosalanejad
Position
Ph.D student
Other areas of specialty/work
Street address
No. 7916839319, Vice chancellor for research, Shahid Mohammadi Hospital, Bandarabbas
City
Bandarabbas
Postal code
Phone
+98 76 3333 7192
Fax
Email
nmosalanezhad467@gmail.commosalanejad@hums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Najmehsadat Mosalanejad
Position
Ph.D student
Other areas of specialty/work
Street address
No. 7916839319, Vice chancellor for research, Shahid Mohammadi Hospital, Bandarabbas