determination Effect of Vitamin D Intake on Maternal of Delivery on prognosis at two years
Design
A concealed, randomized, blinded, controlled clinical trial with a parallel group design of 122 mother, enrolled between January 2020 and September 2021
Settings and conduct
The design will be a one-blind clinical trial under the supervision of Mashhad University of Medical Sciences in 1398-1400. Premature infants less than 37 weeks gestation of mothers receiving vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours before delivery) were compared with infants of mothers who did not receive vitamin D at two years of age. Evaluation of children's development is performed with the Denver-2 test. The level of vitamin D in the mother and infant is measured.
Participants/Inclusion and exclusion criteria
Included:Pregnant mothers less than 37 weeks with delivery symptoms
Excluded: History of developmental delay in the family
Intervention groups
Pregnant mothers who are less than 37 weeks old with symptoms of delivery who have received vitamin D as an intervention group and mothers who have not received vitamin D as a control group are included in the study.
Main outcome variables
Child Development at two years
General information
Reason for update
Acronym
Vitamin D prognosis
IRCT registration information
IRCT registration number:IRCT20110807007244N4
Registration date:2020-06-26, 1399/04/06
Registration timing:registered_while_recruiting
Last update:2020-06-26, 1399/04/06
Update count:0
Registration date
2020-06-26, 1399/04/06
Registrant information
Name
Hassan Boskabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 515 3987
Email address
boskabadih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D intake in mothers with preterm labor on prognosis of children at two years of age
Public title
The effect of vitamin D intake of mother in labor on the prognosis of premature children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant woman with gestational age less than 37 weeks with symptoms of labor
Exclusion criteria:
Infants with a history of known neuro degenerative diseases in the family
congenital anomaly
congenital infection
death in the delivery room
Severe asphyxia
mothers with drug abuse
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on simple random method using table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
The final outcome assessor i.e the researcher who will ultimately evaluate the children in terms of the outcome of the study(prognosis), is blinded of group allocations
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Ahmadabad ST.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.078
Health conditions studied
1
Description of health condition studied
Vitamin D Deficiency, prematurity,Child Prognosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of child development
Timepoint
6,12 and 18 month
Method of measurement
denver developmental screening test
Secondary outcomes
1
Description
Child development
Timepoint
Two years
Method of measurement
denver developmental screening test
Intervention groups
1
Description
Pregnant mothers less than 37 weeks with delivery symptoms who injected one dose of 50,000 units of vitamin D within 72 hours before delivery as intervention groups.
Category
Prevention
2
Description
Control group: No intervention. In mothers of control group, routine cares will be done.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hassan Boskabadi
Street address
Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
boskabadih@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
boskabadih@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
boskabadih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available