Evaluation and Comparison of mean serum Vitamin D, Total calcium, Phosphorus, Alkalin phosphatase and Clinical signs and Wrist radiographic changes in newborns receiveing 400 Vs 600 U Vit D daily at the end of fifth weeks.
Design
Randomised, parallel group trial with blinded outcome assessment. Randomisation was centralised with Permuted block randomization
Settings and conduct
This study is randomized clinical trial conduct in Alzahra and Shahid beshti hospitals affiliated to Isfahan university of medical sciences. For first group and second group Vitamin D begin 400 u/day and 600 U/day respectively. Neonatologist prescribes drug. Fellow and statistical consultant have no any notice about dosage of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Newborns with GA below 32 W
- Exclusive breastfeeding
- Consent of parents for participation in study
Exclusion criteria:
- Vitamin D deficiency in mother
- Perinatal asphyxia
- IUGR
- Pre Gestational and Gestational Diabetes mellitus
Intervention groups
For first group Vitamin D begin 400 u/day from seventh day of life.At fifth week of life Total calcium, Phosphore, Alkalin phosphatase measure and if Alkalin phosphatase exceed from 1000 U/l radiography of wrist will be requested and radiologist report the graphy. fellow record clinical, laboratory and radiologic signs. for second group Vitamin D begin 400 u/day from seventh day of life. The other follow ups are similar to group 1.
Main outcome variables
serum Vitamin D, Total calcium, Phosphore, Alkalin phosphatase, Clinical sign and Wrist radiographic change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150423021910N7
Registration date:2021-01-14, 1399/10/25
Registration timing:registered_while_recruiting
Last update:2021-01-14, 1399/10/25
Update count:0
Registration date
2021-01-14, 1399/10/25
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 400 U Vs 600 U daily on Prevention of Osteopenia of Prematurity in preterm newborns with gestational age below 32 week
Public title
Appropriate Dose of Vitamin D on Prevention of Osteopenia of Prematurity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm newborns with Gestational age below 32w
Exclusive breast feeding
Use of milk fortifier 1 gr per 25 cc of breast milk
Reach of full enteral feeding during first 10 days of life
Discontinue of TPN during first 10 days of life
Normal Vitamin D level in Mothers during Pregnancy
Exclusion criteria:
Lack of perinatal Asphyxia
Lack of IUGR
Lack of Pre-Gestational and Gestational diabetes mellitus
Lack of use of drugs interfere with Vitamin D metabolism
Age
From 1 day old to 35 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The infants were randomly allocated to either the 400 U or 600 U of Vitamin D by a method using permuted block randomization. Block size is 4. Randomization achieve through Random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neonatologist prescribe Vitamin D but Neonatology fellowship and Epidemiologist don`t know which newborns receive 400 U or 600 U Vitamin D
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciense
Street address
Hezarjerib bolvar, Isfahan University of Medical Sciense
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-31, 1399/10/11
Ethics committee reference number
IR.MUI.MED.REC.1399.869
Health conditions studied
1
Description of health condition studied
Osteopenia of prematurity
ICD-10 code
M81.9
ICD-10 code description
Osteoporosis, unspecified
Primary outcomes
1
Description
Total serum calcium
Timepoint
Five weeks after intervention
Method of measurement
colorimetery
2
Description
Serum phosphorus
Timepoint
Five weeks after intervention
Method of measurement
colorimetery
3
Description
Serum alkaline phosphatase
Timepoint
Five weeks after intervention
Method of measurement
colorimetery
4
Description
Radiographic changes of wrist
Timepoint
Five weeks after intervention
Method of measurement
Report of Radiologist
5
Description
Clinical symptoms of osteopenia
Timepoint
During study
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Every 24 hours 25 drops equal to 1 cc of drop Vit D formulated in Alhavi Pharmacy company
Category
Prevention
2
Description
Intervention group 2: Every 24 hours 37 drops equal to 1.5 cc of drop Vit D formulated in Alhavi Pharmacy company
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2006
Email
b_barekatain@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahid beheshti hospitals
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Felezi Bridge
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3236 3600
Email
b_barekatain@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezarjerib bolvar, Isfahan University of Medical Sciense
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 3405
Email
b_barekatain@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Barekatain
Position
Faculty members of Isfahan University of Medical Scienses
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjerib boulevard, Isfahan University of Medical Scienses
City
Isfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3261 6670
Fax
+98 31 3261 6173
Email
b_barekatain@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Barekatain
Position
Faculty members of Isfahan University of Medical Scienses
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjerib boulevard, Isfahan University of Medical Scienses
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3261 6670
Fax
+98 31 3261 6173
Email
b_barekatain@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Barekatain
Position
Faculty members of Isfahan University of Medical Scienses
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjerib boulevard, Isfahan University of Medical Scienses
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3261 6670
Fax
+98 31 3261 6173
Email
b_barekatain@med.mui.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