Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000874213
Ethics application status
Approved
Date submitted
6/10/2009
Date registered
7/10/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
This is a randomised study to assess the safety and efficacy of a high dose vitamin D supplement compared to the standard vitamin D therapy in children.
Scientific title
A study to assess the safety and efficacy of stoss therapy (high dose vitamin D supplement) compared to standard daily therapy in children diagnosed with simple vitamin D deficiency.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 251957 0
Condition category
Condition code
Diet and Nutrition 252142 252142 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An oral intervention of 100,000 IU cholecalciferol weekly for 4 weeks with calcium supplementation 500mg daily for 4 weeks.
Intervention code [1] 241368 0
Treatment: Drugs
Comparator / control treatment
An oral active control of 5000 IU cholecalciferol daily for 90 days with calcium supplementation 500mg daily for 90 days.
Control group
Dose comparison

Outcomes
Primary outcome [1] 253015 0
Normalisation of 25-hydroxyvitamin D levels to > 50 nmol/L by blood analysis.
Timepoint [1] 253015 0
At 12 weeks following randomisation.
Primary outcome [2] 253016 0
Normalisation of alkaline phosphatase levels indicates restoration of bone mineral homeostasis by blood analysis.
Timepoint [2] 253016 0
At 12 weeks following randomisation.
Secondary outcome [1] 257814 0
Safety measure of urinary calcium: creatinine ratios.
Timepoint [1] 257814 0
At 4 and 12 weeks following randomisation.
Secondary outcome [2] 257819 0
Safety measure of other biochemical variables by blood analysis.
Timepoint [2] 257819 0
Following randomisation, blood analysis at 4 weeks to assess alkaline phosphatase concentrations and hypercalcaemia and at 12 weeks to assess for normalisation of mineral homeostasis.
Secondary outcome [3] 257836 0
Bone Age Assessment
Timepoint [3] 257836 0
At the baseline visit and only at 12 weeks to assess for resolution if rickets is present on x-ray.
Secondary outcome [4] 257837 0
Adherence as assessed by return medication.
Timepoint [4] 257837 0
At 4 weeks following randomisation for the high dose group and at 12 weeks following randomisation for the low dose group.

Eligibility
Key inclusion criteria
Diagnosis of simple Vitamin D deficiency, <50 nmol/L.
Be under the care of Endocrinologist and / or Refugee Clinic paediatrician
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing medical condition predisposing to Vitamin D deficiency e.g malabsorption.
Bone active medication e.g bisphosphonates. anticonvulsants.
No metabolic cause for rickets

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent obtained after diagnosis of simple Vitamin D deficiency (<50 nmol/L) for randomise treatment for either the stoss (high dose therapy) or to the low dose standard treatment.
Concealment procedures using random number tables with equal numbers by an independent person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using random number tables.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243841 0
Hospital
Name [1] 243841 0
The Children's Hospital at Westmead
Country [1] 243841 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hainesworth Street and Hawkesbury Road Locked Bag 4001 Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 237191 0
None
Name [1] 237191 0
Address [1] 237191 0
Country [1] 237191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243965 0
The Royal Alexander Hospital for Children Ethics Committee
Ethics committee address [1] 243965 0
Cnr Hainesworth Street and Hawkesbury Road Westmead Locked Bag 4001 Westmead NSW 2145
Ethics committee country [1] 243965 0
Australia
Date submitted for ethics approval [1] 243965 0
Approval date [1] 243965 0
Ethics approval number [1] 243965 0
2006 / 107

Summary
Brief summary
This study is a randomised study that will investigate the safety and effacy of stoss therapy (high dose weekly vitamin D supplementation for 4 weeks) compared to daily vitamin D for 3 months. The hypothesis is that stoss vitamin D therapy is a safe and effective treatment for vitamin D deficency. If proven safe and effective, stoss therapy would have significant advantages where therapy is shortened, thus improving compliance and ultimate recovery from Vitamin D deficiency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30351 0
Address 30351 0
Country 30351 0
Phone 30351 0
Fax 30351 0
Email 30351 0
Contact person for public queries
Name 13598 0
Dr. Craig Munns
Address 13598 0
Genetic and Metabolic Bone Disorders
Institute of Endocrinology and Diabetes
Cnr Hainsworth Street and Hawkesbury Road Locked Bag 4001 Westmead NSW 2145
Country 13598 0
Australia
Phone 13598 0
+61 2 98453200
Fax 13598 0
+61 2 98453170
Email 13598 0
[email protected]
Contact person for scientific queries
Name 4526 0
Dr. Craig Munns
Address 4526 0
Genetic and Metabolic Bone Disorders
Institute of Endocrinology and Diabetes
Cnr Hainsworth Street and Hawkesbury Road Locked Bag 4001 Westmead NSW 2145
Country 4526 0
Australia
Phone 4526 0
+61 2 98453200
Fax 4526 0
+61 2 98453170
Email 4526 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
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Documents added automatically
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