Trial Review

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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
Sex
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
20/05/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
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
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
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
[email protected]
Contact person for public queries
Name 17362 0
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
[email protected]
Contact person for scientific queries
Name 8290 0
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.