Comparing the effect of different doses of vitamin D supplement on the level of serum 25(OH) vitamin D and bone metabolism related factors in preterm neonates
Evaluation of the effect of different doses of vitamin D supplement on the level of serum 25(OH)vitamin D and bone metabolism related factors in preterm neonates
Design
Randomized Clinical trial with parallel groups
Settings and conduct
This study is performed on 100 premature infants in Hajar Hospital in Shahrekord. At the beginning of the study blood samples are taken from all the infants for checking Calcium, Phosphorus, 25 Hydroxy Vitamin D, and Alkaline Phosphatase levels.These babies are divided into 2 groups of fifty. Groups Are being unified based on type of residence, rural and urban, as well as vitamin D level.The onset of vitamin D prescription in newborns begins when breastfeeding has reached 150 cc/kg. The first group receives 400 and the second group receives 800 units of vitamin D daily.The treatment is continued until Modified age 40 weeks after LMP, and in this time the mentioned lab tests are cheked again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age 28 to 34 weeks; the absence of major disorders and malformations; the absence of systemic diseases, such as asphyxia and cholestasis. Exclusion criteria: supportive nutrition for more than 2 weeks; use of anticonvulsant and anti HIV drugs by the infant's mother; use of injectable vitamin D during the study; formula feeding; nephrocalcinosis in the infant.
Intervention groups
The amount of 300 units of vitamin D is given to Infants in two groups through FMS supplement and then received vitamin D reaches 400 and 800 units per day with the use of two types of vitamin D drops .
The first group: 100 units of A + D drop (Behsa) plus distilled water. The second group: 100 units of A + D drop(Behsa) plus 400 units of vitamin D drop 1000 units per cc (vitabiotics).
Main outcome variables
Levels of vitamin D; calcium; phosphorus; alkaline phosphatase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N4
Registration date:2019-03-03, 1397/12/12
Registration timing:registered_while_recruiting
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-25, 1397/05/03
Expected recruitment end date
2019-07-25, 1398/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of different doses of vitamin D supplement on the level of serum 25(OH) vitamin D and bone metabolism related factors in preterm neonates
Public title
Effect of vitamin D supplementat on the level of serum vitamin D in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 28 and 34 weeks
The absence of major disorders and malformations
The absence of systemic diseases, such as asphyxia and cholestasis
Exclusion criteria:
Supportive nutrition for more than 2 weeks
Use of anticonvulsant and anti HIV drugs by the infant's mother
Use of injectable vitamin D during the study
Formula feeding
Nephrocalcinosis in the infant
Age
From 1 day old to 30 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Cases are randomized using random allocation through the software. In this way, after the selection of 100 preterm infants that have the inclusin criterias, neonates are randomly assigned to one of the two intervention groups by statistical software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.SKUMS.REC.1397.100
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency in premature infants
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Serum level of 25 hydroxy vitamin D
Timepoint
Beginning of study, Modified age 40 weeks after LMP
Method of measurement
Blood sample
2
Description
Serum level of calcium
Timepoint
Beginning of study, Modified age 40 weeks after LMP
Method of measurement
Blood sample
3
Description
Serum level of Phosphorus
Timepoint
Beginning of study, Modified age 40 weeks after LMP
Method of measurement
Blood sample
4
Description
Serum level of Alkaline phosphatase
Timepoint
Beginning of study, Modified age 40 weeks after LMP
Method of measurement
Blood sample
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus distilled water
Category
Treatment - Drugs
2
Description
Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus 400 units of vitamin D drop (1000 units per cc vitabiotics)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Nasim Rahimi
Street address
Hajar Hospital,Nursing Street ,Kashan Blvd,Shahrekord City,Chahar Mahal and Bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3222 0016
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Seyed Kamal Solati
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
choopani.r@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
choopani.r@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
choopani.r@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Hajar Hospital in Shahrekord, nasim18r@yahoo.com
What processes are involved for a request to access data/document
after the investigation of resercher request and presentation of required documents will be accessible.