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Trial registered on ANZCTR

Registration number

ACTRN12611001177943

Ethics application status

Approved

Date submitted

10/11/2011

Date registered

11/11/2011

Date last updated

11/11/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparison of depot versus daily vitamin D3 for supplementation in refugees in Western Australia

Scientific title

Randomized controlled trial comparing depot and daily vitamin D3 therapy in 0-16 year old refugees in Western Australia looking at the change in 25(OH)D levels as the primary outcome

Secondary ID [1]

nil

Universal Trial Number (UTN)

1111-1125-4879

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants received oral vitamin D3 supplementation. Depending on their 25 hydroxivitamin D (25(OH)D) levels at presentation doses were as follows:
1. 25(OH)D < 27.5 nmol/L: either vitamin D3 200,000 IU depot once (as a one-off dose) or 5000 IU daily for 6-8 weeks
2. 25(OH)D 27.5-78 nmol/: either vitamin D3 100,000 IU depot as a on-off dose or 2500 IU daily for 6-8 weeks.
25(OH)D measurement was repeated 6-8, 14-16, 20-22 and 26-34 weeks later and treatment continued according to the above mentioned schedule if levels were <78 nmol/L. Time points were determined from the starting date of therapy. Variations occured due to participant-availability.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Daily therapy is the current standard treatment. The group on daily medication will be the comparator group.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Change in 25(OH)D levels. Biochemical analysis using Nichols RIA assay.

Timepoint [1]

Every 6-8 weeks for 6 months. Time points were determined from the starting date of therapy. Variations occured due to participant-availability.

Secondary outcome [1]

Clinical symptoms of vitamin D deficiency as seen at clinical assessment, including rachitic rosary, leg deformities, widened epiphyses on x-rays

Timepoint [1]

Every 6-8 weeks for 6 months. Time points were determined from the starting date of therapy. Variations occured due to participant-availability.

Secondary outcome [2]

Surrounding factors including sun exposure, sun protection, clothing and diet. Assessment through questionnaires and a 3-day food diary.

Timepoint [2]

Every 6-8 weeks for 6 months. Time points were determined from the starting date of therapy. Variations occured due to participant-availability.

Eligibility

Key inclusion criteria

0-16 year old newly resettled refugees in Western Australia with 25(OH)D levels < 78 nmol/L

Minimum age

0 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Previous vitamin D therapy

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)

Drawing numbers from a sealed opaque envelope

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Even numbers for daily therapy group, uneven numbers for depot therapy group. In families with more than one affected member, participants were randomised to the same treatment arm

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

nil

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Margaret Hospital for Children

Address [1]

Dept of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Margaret Hospital for Children

Address

Dept of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Princess Margaret Hospital for Children

Address [1]

Dept of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of Western Australia

Address [1]

School of Paediatrics and Child Health
Subiaco, WA 6008

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Notre Dame

Address [2]

Institute of Health and Rehabilitation Research
Fremantle, WA

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Ethics Committee

Ethics committee address [1]

Princess Margaret Hospital
Roberts Road
Subiaco, WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2008

Approval date [1]

21/08/2008

Ethics approval number [1]

1564/EP

Summary

Brief summary

After arrival in Western Australia resettled refugees undergo an initial health assessment that includes testing for 25(OH) vitamin D. An internal audit in 2007/8 revealed that of the 2400 patients assessed, 45% were vitamin D deficient (25(OH)D:<27.5 nmol/L) and 54% insufficient (25(OH)D:27.5-78 nmol/L). The use of high-dose depot vitamin D therapy is increasing, but there are few data on its use in children. 
OBJECTIVE: To compare the efficiency and safety of daily versus depot oral vitamin D supplementation in refugee children 
METHODS: Refugee children aged 0-16 years with 25(OH)D levels <78 nmol/L were recruited through a refugee tertiary clinic and randomized as follows: those with vitamin D deficiency received either vitamin D3 200,000 IU depot or 5000 IU daily and those with vitamin D insufficiency 100,000 IU depot or 2500 IU daily. 25(OH)D measurement was repeated 6-8 and 14-16 an 22-24 weeks later and treatment continued if levels were <78 nmol/L. Other biochemical parameters included calcium and alkaline phosphatase (ALP). Data on sun exposure, season , diet, country of origin and skin pigmentation were collected.   
RESULTS: A first analysis looking at 84 subjects with complete data sets revealed significant improvements in 25(OH)D between visits (p<0.05) without difference between depot and daily treatment groups. Sun exposure and oral calcium intake were very low. The study is ongoing. 
CONCLUSIONS: Supplementation with both daily and depot vitamin D3 resulted in similar improvements and could normalize vitamin D levels during the initial treatment phase. Depot vitamin D3 therapy was a safe and well accepted therapeutic option. It was difficult to achieve long term improvement even under controlled conditions. Support by public health initiatives is required.

Trial website

nil

Trial related presentations / publications

U.Wadia, S.Cherian, A.Thambiran, D.Burgner, A.Siafarikas: Randomised controlled trial comparing daily versus depot vitamin D3 for the treatment of vitamin D deficiency in 0-16 year old refugees in Western Australia. 3rd joint meeting of the European Calcified Tissue Society and the International Bone and Mineral Society (ECTS/IBMS), Athens, Greece, May 2011

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Clin Assoc Professor Aris Siafarikas

Address

Princess Margaret Hospital
Dept Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408090

Fax

+61893408605

[email protected]

Contact person for scientific queries

Name

Clin Assoc Professor Aris Siafarikas

Address

Princess Margaret Hospital
Dept Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408090

Fax

+61893408605

[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

Source	Title	Year of Publication	DOI
Embase	Randomised controlled trial comparing daily VerSus depot vitamin D3 therapy in 0-16-year-old newly settled refugees in Western Australia over a period of 40 weeks.	2018	https://dx.doi.org/10.3390/nu10030348

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

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