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Trial registered on ANZCTR


Registration number
ACTRN12615000642583
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
22/06/2015
Date last updated
22/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infants of Vitamin D deficient mothers-trial comparing Pentavite and Vitamin D3 supplement-effect on Vitamin D level at 6 weeks
Scientific title
infants of vitamin d deficient mothers-trial comparing 2 supplement options with vitamin D levels repeated at 6 weeks
Secondary ID [1] 281563 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vitamin d deficiency 286376 0
Condition category
Condition code
Metabolic and Endocrine 286618 286618 0 0
Diabetes
Metabolic and Endocrine 288194 288194 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
assess vitamin d levels at day 3 of life and 6 weeks of life by heel prick blood tests.2 groups then randomly assigned to receive oral Pentavite 0.45mls daily for 6 weeks or single dose of vitamin D3 50000 units orally on day 3 once low level established.
Intervention code [1] 284758 0
Treatment: Other
Comparator / control treatment
Pentavite group
Control group
Active

Outcomes
Primary outcome [1] 287031 0
assessment of efficacy of single 50000unit vit d3 dose vs pentavite for 6 weeks with blood level of vitamin D at 6 weeks.
Timepoint [1] 287031 0
6 weeks
Secondary outcome [1] 297246 0
assess need for further treatment-if vitamin D level still low on blood levels may need further treatment period.
Timepoint [1] 297246 0
3 months

Eligibility
Key inclusion criteria
infants of vitamin d deficient mothers
Minimum age
3 Days
Maximum age
42 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
those not fully breast fed

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
infants of vitamin d deficient mothers detected at birth and vitamin d level performed with newborn screening test on day 3 then will receive either vitamin d 3 or pentavite;selection process random with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by blind envelope selection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286347 0
Self funded/Unfunded
Name [1] 286347 0
Address [1] 286347 0
Country [1] 286347 0
Primary sponsor type
Hospital
Name
cabrini hospital
Address
183 wattletree rd malvern victoria 3144
Country
Australia
Secondary sponsor category [1] 284028 0
Hospital
Name [1] 284028 0
monash medical centre
Address [1] 284028 0
246 clayton rd clayton victoria 3168
Country [1] 284028 0
Australia
Secondary sponsor category [2] 285136 0
None
Name [2] 285136 0
Address [2] 285136 0
Country [2] 285136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288428 0
cabrini hospital human research ethics committee
Ethics committee address [1] 288428 0
Ethics committee country [1] 288428 0
Date submitted for ethics approval [1] 288428 0
Approval date [1] 288428 0
27/07/2012
Ethics approval number [1] 288428 0

Summary
Brief summary
the aim is to define the appropriate type and length of treatment with vitamin d for infants of vitamin d deficient mothers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34115 0
Dr Simon Costello
Address 34115 0
Cabrini Childrens Centre
183 Wattletree Rd
Malvern
3144
Country 34115 0
Australia
Phone 34115 0
613 95098688
Fax 34115 0
Email 34115 0
costellosimon@bigpond.com
Contact person for public queries
Name 17362 0
Dr Dr Simon Costello
Address 17362 0
Cabrini Childrens Centre
183 Wattletree Rd Malvern victoria 3144
Country 17362 0
Australia
Phone 17362 0
61 3 95098688
Fax 17362 0
Email 17362 0
costellosimon@bigpond.com
Contact person for scientific queries
Name 8290 0
Dr Simon Costello
Address 8290 0
Cabrini Childrens Centre
183 Wattletree Rd Malvern Victoria 3144
Country 8290 0
Australia
Phone 8290 0
61 3 95098688
Fax 8290 0
Email 8290 0
costellosimon@bigpond.com

No information has been provided regarding IPD availability
Summary results
No Results