Protocol summary
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Study aim
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Comparison of ROP incidence in preterm infants of mothers receiving and not receiving vitamin D
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Design
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A concealed, randomized, blinded, controlled clinical trial with a parallel group design of 93 mother, enrolled between January 2020 and September 2020
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Settings and conduct
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The design will be a one-blind clinical trial under the supervision of Mashhad University of Medical Sciences in 2020. Premature infants less than 34 weeks of gestation of mothers received vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours ago) were compared with infants of mothers not use vitamin D, in terms of Retinopathy of prematurity(ROP). Diagnosis of ROP will be determined by an eye examination by a retina specialist. The level of vitamin D in the mother is measured after vitamin D is injected. A sample containing 1.5 cc of whole blood will be taken from the umbilical cord for measure of vitamin D. The prepared samples will be centrifuged at -20 ° C and send for laboratory evaluation. Vitamin D level will be measured by Elisa Reader RT2100c Made in Germany and Elisa Washing Machine .
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Participants/Inclusion and exclusion criteria
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Pregnant woman with gestational age less than 34 weeks will enter the study, Neonates with clear congenital anomaly, congenital infection ,death in the delivery room, Severe asphyxia, mothers with drug abuse will be excluded from the study.
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Intervention groups
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The intervention group received 50,000 units of vitamin D injections 72 hours before birth
The control group received no medication.
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Main outcome variables
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with or without ROP
General information
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Reason for update
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Matching the date of approval of the ethics committee with the clinical trial and modifying the sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110807007244N3
Registration date:
2020-02-06, 1398/11/17
Registration timing:
prospective
Last update:
2022-05-24, 1401/03/03
Update count:
1
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Registration date
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2020-02-06, 1398/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Vitamin D Intake on Maternal of Delivery on Retinopathy of prematurity in Infants
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Public title
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Effect of Vitamin D Intake on Maternal of Delivery on Retinopathy of prematurity in Infants
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant woman with gestational age less than 34 weeks with symptoms of labor
Exclusion criteria:
congenital anomaly
congenital infection
death in the delivery room,
Severe asphyxia
mothers with drug abuse
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
93
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is based on simple random method using table of random numbers
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The final outcome assessor i.e the researcher who will ultimately evaluate the children in terms of the outcome of the study(ROP), is blinded of group allocations
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-03, 1398/06/12
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1398.526
Health conditions studied
1
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Description of health condition studied
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Retinopaty of prematurity
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ICD-10 code
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H35.1
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ICD-10 code description
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Retinopathy of prematurity
Primary outcomes
1
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Description
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present or unrepresented Retinopathy of prematurity
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Timepoint
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4 week after births
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Method of measurement
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retinal exam
Intervention groups
1
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Description
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Intervention group: Pregnant mothers less than 34 weeks presenting with delivery symptoms while have Received 50000 Iu vitamin D
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Category
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Prevention
2
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Description
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Control group: Pregnant mothers less than 34 weeks presenting with delivery symptoms with routine care
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Category
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N/A
1
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Sponsor
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Grant name
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Mashhad University of Medical Sciences
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Grant code / Reference number
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980131
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data of Vitamin D on ROP
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When the data will become available and for how long
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4 moth after end of research
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To whom data/document is available
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Mashhad University of Medical Sciences
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Under which criteria data/document could be used
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Ask a permission Mashhad University of Medical Sciences
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From where data/document is obtainable
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Mashhad University of Medical Sciences
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What processes are involved for a request to access data/document
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Ask a permission Mashhad University of Medical Sciences
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Comments
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