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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] 273355 0
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 279132 0
Condition category
Condition code
Metabolic and Endocrine 279322 279322 0 0
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] 283703 0
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] 279934 0
Change in 25(OH)D levels. Biochemical analysis using Nichols RIA assay.
Timepoint [1] 279934 0
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] 294802 0
Clinical symptoms of vitamin D deficiency as seen at clinical assessment, including rachitic rosary, leg deformities, widened epiphyses on x-rays
Timepoint [1] 294802 0
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] 294803 0
Surrounding factors including sun exposure, sun protection, clothing and diet. Assessment through questionnaires and a 3-day food diary.
Timepoint [2] 294803 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284183 0
Hospital
Name [1] 284183 0
Princess Margaret Hospital for Children
Address [1] 284183 0
Dept of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country [1] 284183 0
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] 269139 0
Hospital
Name [1] 269139 0
Princess Margaret Hospital for Children
Address [1] 269139 0
Dept of Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country [1] 269139 0
Australia
Other collaborator category [1] 260337 0
University
Name [1] 260337 0
University of Western Australia
Address [1] 260337 0
School of Paediatrics and Child Health
Subiaco, WA 6008
Country [1] 260337 0
Australia
Other collaborator category [2] 260338 0
University
Name [2] 260338 0
University of Notre Dame
Address [2] 260338 0
Institute of Health and Rehabilitation Research
Fremantle, WA
Country [2] 260338 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286147 0
Child and Adolescent Health Service Ethics Committee
Ethics committee address [1] 286147 0
Princess Margaret Hospital
Roberts Road
Subiaco, WA 6008
Ethics committee country [1] 286147 0
Australia
Date submitted for ethics approval [1] 286147 0
01/05/2008
Approval date [1] 286147 0
21/08/2008
Ethics approval number [1] 286147 0
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 33312 0
Address 33312 0
Country 33312 0
Phone 33312 0
Fax 33312 0
Email 33312 0
Contact person for public queries
Name 16559 0
Clin Assoc Professor Aris Siafarikas
Address 16559 0
Princess Margaret Hospital
Dept Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 16559 0
Australia
Phone 16559 0
+61893408090
Fax 16559 0
+61893408605
Email 16559 0
Aris.Siafarikas@health.wa.gov.au
Contact person for scientific queries
Name 7487 0
Clin Assoc Professor Aris Siafarikas
Address 7487 0
Princess Margaret Hospital
Dept Endocrinology and Diabetes
Roberts Road
Subiaco, WA 6008
Country 7487 0
Australia
Phone 7487 0
+61893408090
Fax 7487 0
+61893408605
Email 7487 0
Aris.Siafarikas@health.wa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary