Comparison of Calcitriol and Cholecalciferol on biochemical markers of Metabolic Bone Disease in very low birth weight infants .
Design
Randomized Control Trials ,Double blind
Settings and conduct
This study will be in a setting of Neonatal Intensive Care Unit of Alzahra teaching hospital of Tabriz.After receiving of parental consent 72 VlBW Infants recruited . After receiving to full feed level( 120 cc/kg/d of Breast milk ) they are randomly divided in two groups: Control group receives400 IU/day 25 hydroxy vitamin D3 (cholecalciferol) n=35) and study group receives0.2 µg/kg/day Calcitriol (n= 37) .Biochemical markers will be checked as baseline ,after 3 and 6 weeks of treatment and before discharge.
Participants/Inclusion and exclusion criteria
inclusion factors:
Very low birth weight infants (<1500 gr) born in alzahra teaching hospital
infants who their parent has signed satisfaction factor
infants after aging 2 weeks that can tolerate (120cc/kg/day) of breast milk or breast milk with formula
exclusion factors:
infants with major malformation
infants with congenital cardiac disease
infants with familial bone disease background
infants receiving corticosteroids
Intervention groups
Group 1( control) receives calcitriol 0.2 µg/kg/day and group 2 ( study )receives cholecalciferol 400 IU/day .Drugs are calculated to cc and pooled in a insulin syringe.Infants will received calcitriol or cholecalciferol during feeding with breast milk through NG tube. Supplementation will be continued till discharge
Main outcome variables
biochemical markers of metabolic bone disease including ALP, VitD3 , P ,Ca , PTH and tubular reabsorbtion of phosphate(TRP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N28
Registration date:2018-06-10, 1397/03/20
Registration timing:retrospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
empty
Scientific title
Comparison of Calcitriol and Cholecalciferol on biochemical markers of Metabolic Bone Disease in very low birth weight infants
Public title
Evaluation of effect of different type of vitamin D on biochemical markers of osteopenia of Prematurity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inborn Very low birth weight infants (<1500g) in Alzahra Teaching hospital
Taking consent of parents
Tolerating 120cc/kg/day breast milk or breast milk with formula ( Full feed )
Exclusion criteria:
Infants with major malformation
Infants with congenital cardiac disease
Infants with familial history of bone disease
Infants receiving corticosteroids
Infants born from mothers with renal failure
Age
From 14 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
4
Blood sampling and urine
Actual sample size reached:
72
More than 1 sample in each individual
Actual sample size in each individual:
4
Blood sampling and urine
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be by systematic randomization methods and by random numbers made by computer
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients randomly divided in two groups . One group receive Cholecaciferol (VitD3) 400 IU/Day and the other Caliteriol (Rocaltrol) 0.2 µg/kg/day.Before and after 3 and 6 weeks after starting the treatments and before discharge lab data including :ALP , P , Ca ,TRP ,Serum VitD3,PTH will be checked .Data will be collected by a research nurse who is blind to the groups of the infants.
Data will be analyzed by a statistician who will be blind to the groups .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
Reasearch and Technology Deputy of tabriz medical university ,golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
IR.TBZEDMED.REC.1395.1035
Health conditions studied
1
Description of health condition studied
metabolic bone disease in very low birth weight infants
ICD-10 code
E55.0
ICD-10 code description
decreased bone mineral content relative to the expected level of mineralization seen in conjunction with biochemical and/or radiographic changes
Primary outcomes
1
Description
Biochemical markers of Osteopenia Prematurity including :ALP , P , Ca
Timepoint
Biochemical marker measurement at baseline , 3 and 6 weeks later starting treatment and before discharge
Method of measurement
Rochas.Anzimatic method by Selectra auto analyzer
2
Description
serum Vit D3 Level
Timepoint
At baseline , 3 and 6 weeks later after treatment and before discharge
Method of measurement
Electrochemiluminescence method by Alexis
3
Description
Serum parathormon level
Timepoint
Biochemical marker measurement at baseline , 3 and 6 weeks later after treatment and before discharge
Method of measurement
serum level of parathormon hormon is measured with electrochemiluminescence method by Alexis Rochas.
Secondary outcomes
1
Description
Calculation of Tubular reabsorption of phosphate
Timepoint
At the binning of the study , 3 ,6 weeks after treatment and before discharge
Method of measurement
TRP = 1-(Urine phosphate x Pcreatinine/ Pphosphate x U creatinine)
Intervention groups
1
Description
Intervention group: calcitriol group receives calcitriol 0.2 µg/kg/day ( From calcitriol pearl's content pooled in insulin syringe). Infants receives calcitriol during feeding with breast milk through NG tube. Supplementation will continue untill discharge.
Category
Treatment - Drugs
2
Description
Control group:cholecalciferol group receives cholecalciferol 400 IU/day (cholecalciferol's drops pooled in insulin syringe). Infants receives calcitriol with milk through NG tube. Supplementation will continue till discharge
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching hospital of Tabriz
Full name of responsible person
Mohammadbagher Hosseini MD
Street address
South Artesh street ,Alzahra Teaching hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9162
Fax
+98 41 3556 6449
Email
hosseini.neo@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghacem Joiban Phd
Street address
Golgasht Street ,Tabriz Universit Campous
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Taher entezar maleki
Position
Associated Professor of clinical pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
Deanpharmacy@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher entezar maleki
Position
Associated professor of clinical pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university ,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51666414766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nafiseh Hosseini
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university ,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
nafisehhosseyni@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available