ANZCTR - Registration

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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

Condition category

Condition code

Metabolic and Endocrine

Other metabolic disorders

Diet and Nutrition

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]

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]

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]

6 weeks after commencement of treatment

Secondary outcome [1]

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]

6 weeks, 6 months after the commencement of treatment

Secondary outcome [2]

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]

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?

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]

Hospital

Name [1]

Paul Carmen fellowship/scholarship

Address [1]

Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA

Country [1]

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]

Individual

Name [1]

Andrew Martin

Address [1]

Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Princess Margaret Hospital Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/01/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Jason Tan

Address

Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA

Country

Australia

Phone

+61 08 93407651

Fax

Jason.Tan@health.wa.gov.au or jkgtan@hotmail.com

Contact person for scientific queries

Name

Jason Tan

Address

Princess Margaret Hospital
Roberts Road, Subiaco 6008
Perth, WA

Country

Australia

Phone

+61 08 93408222

Fax

+61 08 93407652

Jason.Tan@health.wa.gov.au or jkgtan@hotmail.com

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

Source	Title	Year of Publication	DOI
Embase	Randomised controlled trial of daily versus stoss vitamin D therapy in Aboriginal children.	2015	https://dx.doi.org/10.1111/jpc.12781

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically