The aim of this study is to evaluate the effect of sun exposure versus vitamin D supplementation for pregnant women with vitamin D deficiency.This double-blind prospective clinical trial will be performed on 80 pregnant women with vitamin D deficiency. patients whom will have improper use of vitamin D, inappropriate exposure to sunlight, preterm labor, having dark skin and lose to follow-up due to various causes, must exit from the study. Group A will be treated with vitamin D 4,000 IU per day for 10 weeks, while group B will be recommended for sun exposure for 30 minutes daily ((from shoulder to fingers and from femur to toes) 30% body surface area) for 10 weeks in summer and between 10 am to 4 pm in direct sunlight. At birth, 25-hydroxyvitamin D3 serum level will be measured in mothers and will be compared with previous one. In addition, head circumference, weight and height of infants in both groups, will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101227998N2
Registration date:2016-12-15, 1395/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Isfahan university of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sun exposure versus vitamin D supplementation for pregnant women with vitamin D deficiency
Public title
Comparison of sun exposure versus vitamin D supplementation for pregnant women with vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Patients who want to cooperate in study and consent to participate in the study; having gestational age 14 to 18 weeks; (serum levels of 25-hydroxyvitamin D3 <30 ngr/ml); single fetus; no history of chronic hypertension, chronic diseases such as musculoskeletal, diabetes, parathyroid, hepatitis, kidney and any kind of malabsorption disorders, skin disease, skin cancer; living in the Isfahan.
Exclusion criteria
withdrawal of the study; improper use of vitamin D; inappropriate exposure to sunlight; preterm labor; having dark skin and loss to follow-up due to various causes.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Isfahan Medical Sciences
Street address
Isfahan, Hezar jarib street, Isfahan university
City
Isfahan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
394132
Health conditions studied
1
Description of health condition studied
vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
vitamin D deficiency , unspecified
Primary outcomes
1
Description
Serum vitamin D level
Timepoint
Pregnant women with gestational age 14 – 18 weeks and after 10 week using medicine or exposure to sunlight
Method of measurement
Serum analysis (nanogram)
Secondary outcomes
1
Description
Infant head circumference
Timepoint
at birth
Method of measurement
standard meter
2
Description
hieght of newborn
Timepoint
At birth
Method of measurement
Standard meter
3
Description
Infant weight
Timepoint
At birth
Method of measurement
Standard scale
Intervention groups
1
Description
Intervention group: will be recommended for sun exposure for 30 minutes daily (from shoulder to fingers and from thigh to toe (30% body surface area) without use of sunscreen) for 10 weeks in summer and between 10 am to 4 pm in direct sunlight
Category
Prevention
2
Description
Control group:will be receive 4 tabs each one include 1000 IU of vitamin D manufactured by Iranian Zahravi Co. per day for 10 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Obstetrics of Beheshti hospital
Full name of responsible person
Azadeh Khorsandi, resident
Street address
Pole Felezy street
City
Isfahan
2
Recruitment center
Name of recruitment center
Department of Obstetrics of Alzahra hospital
Full name of responsible person
Azadeh Khorsandi-resident
Street address
Shohadaye-Sofhe street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Amir Rahimi
Street address
Hezar Jarib street
City
Isfahan
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan 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
Isfahan department of medicin
Full name of responsible person
Azadeh Khorsandi
Position
resident
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Hezar Jarib street, Isfahan
City
Isafahan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31336680048
Fax
-
Email
dr.akhorsandi@gmail.com
Web page address
http://www.mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beheshti hospital
Full name of responsible person
Maryam Hajihashemi
Position
Gynecologist
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Hezar Jarib street,Isfahan
City
Isfahan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3668 0048
Fax
-
Email
m_hajihashemi@med.mui.ac.ir
Web page address
http://www.mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Azadeh Khorsandi
Position
Resident
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3771 6152
Fax
-
Email
dr.akhorsandi@gmail.com
Web page address
http://www.mui.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)