Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001177943
Enrollment
150
Registered
2011-11-11
Start date
2010-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Princess Margaret Hospital for Children
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Previous vitamin D therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026