Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000269235
Ethics application status
Not yet submitted
Date submitted
12/03/2009
Date registered
15/05/2009
Date last updated
15/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of daily versus depot vitamin D3 supplementation on vitamin D deficiency in Aboriginal children and adolescents in metropolitan and rural Western Australia
Scientific title
The efficacy of daily versus depot vitamin D3 supplementation on vitamin D deficiency in Aboriginal children and adolescents in metropolitan and rural Western Australia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 4467 0
Condition category
Condition code
Metabolic and Endocrine 4738 4738 0 0
Other metabolic disorders
Diet and Nutrition 4985 4985 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Depot vitamin D3 supplementation (200,000IU, oral route, once every 6 weeks with 6 weekly maintenance of 35,000IU continued for a duration of 6 months)
Intervention code [1] 4212 0
Treatment: Other
Comparator / control treatment
Daily vitamin D3 supplementation (5,000IU; oral route, 6 weeks duration the maintenance of 400IU daily maintenance for a duration of 6 months)
Control group
Active

Outcomes
Primary outcome [1] 5605 0
Treatment efficacy - rise in vitamin D level of 25nmol/L over 6 weeks. The 25(OH)D3 level will be measured on the DiaSorin Liaison. A rise of 25nmol/L over 6 weeks has been chosen as a marker of efficacy as previous studies suggests that adequate treatment with vitamin D supplements will lead to a minimum average rise of 25nmol/L. This increase also correlates with moving to a higher strata group in our predetermined strata of vitamin D levels (<25nmol/L is deficient; 25-50nmol/L is moderate insufficiency; 50-78nmol/L is mildly insufficient)
Timepoint [1] 5605 0
6 weeks after commencement of treatment
Secondary outcome [1] 9434 0
Difference between mean rise in vitamin D level in the daily and depot groups. The 25(OH)D3 levels will be measured on the DiaSorin Liaison.
Timepoint [1] 9434 0
6 weeks, 6 months after the commencement of treatment
Secondary outcome [2] 9435 0
Proportion of individuals with a normal vitamin D level at 6 weeks and 6 months. The 25(OH)D3 levels will be measured on the DiaSorin Liaison.
Timepoint [2] 9435 0
6 weeks, 6 months after commencement of treatment

Eligibility
Key inclusion criteria
1. Aboriginal children aged 0-16 years old
2. Attending hospital or attending outpatient clinics
3. Require a blood test as part of their clinical management
4. Have a low vitamin D level (<78nmol/L)
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children already diagnosed with low vitamin D levels and are receiving vitamin D supplementation
2. Children with immune deficiency
3. Children with chronic liver disease
4. Children with chronic renal disease
5. Children with cardiac disease
7. Children taking anticonvulsant medication

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)
Once a potential participant has been identified the research team will approach the participant and their parent/carer and provide them with an information sheet outlining the study. We will also be available to discuss any issues that they may have regarding the study. If they agree to be part of the study then consent will be sought for the questionnaire, blood test and intervention concurrently before the blood test. Allocation will be concealed by contacting the holder of the allocation schedule who is at Princess Margaret Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4656 0
Hospital
Name [1] 4656 0
Paul Carmen fellowship/scholarship
Country [1] 4656 0
Australia
Primary sponsor type
Individual
Name
Jason K Tan
Address
Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA
Country
Australia
Secondary sponsor category [1] 4203 0
Individual
Name [1] 4203 0
Andrew Martin
Address [1] 4203 0
Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA
Country [1] 4203 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6692 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 6692 0
Ethics committee country [1] 6692 0
Australia
Date submitted for ethics approval [1] 6692 0
08/01/2009
Approval date [1] 6692 0
Ethics approval number [1] 6692 0

Summary
Brief summary
The aims of the study are:
1. To examine if vitamin D deficiency is common problem in Aboriginal children in Western Australia (WA)
2. To determine if depot and daily vitamin D therapy have the same therapeutic outcomes.
3. To examine the relationship between vitamin D levels and childhood infections.
4. To determine the predictors of vitamin D deficiency in Aboriginal children

We hyypothesize that:
1. Vitamin D deficiency is a common problem in Aboriginal children in WA
2. Depot vitamin D therapy results in better therapeutic outcomes than traditional daily vitamin D therapy.
2. Children with lower vitamin D levels have a higher burden of childhood infections.
3. Age, sun exposure, skin pigmentation and nutrition will influence vitamin D levels in children
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29389 0
Address 29389 0
Country 29389 0
Phone 29389 0
Fax 29389 0
Email 29389 0
Contact person for public queries
Name 12636 0
Jason Tan
Address 12636 0
Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA
Country 12636 0
Australia
Phone 12636 0
+61 08 93407651
Fax 12636 0
Email 12636 0
[email protected] or [email protected]
Contact person for scientific queries
Name 3564 0
Jason Tan
Address 3564 0
Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA
Country 3564 0
Australia
Phone 3564 0
+61 08 93408222
Fax 3564 0
+61 08 93407652
Email 3564 0
[email protected] or [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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of daily versus stoss vitamin D therapy in Aboriginal children.2015https://dx.doi.org/10.1111/jpc.12781
N.B. These documents automatically identified may not have been verified by the study sponsor.