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Randomized Controlled Trial
. 2018 Mar 13;10(3):348.
doi: 10.3390/nu10030348.

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

Affiliations
Randomized Controlled Trial

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

Ushma Wadia et al. Nutrients. .

Abstract

Vitamin D deficiency is highly prevalent in newly settled refugees in Western Australia (WA). If adherence to daily vitamin D therapy is problematic, depot therapy is a therapeutic alternative. The aim of this study was to compare daily versus depot treatment and factors influencing the therapeutic outcome. Newly settled refugees (n = 151) with 25(OH)D levels less than 78 nmol/L were randomised to receive daily or depot vitamin D therapy with eight weekly interval follow up to 40 weeks. Biochemical and clinical parameters were collected at each visit. Generalized Linear Mixed Models (GLMM) examined the longitudinal changes over time controlling for confounders including age, gender, treatment arm, season, country of refuge/origin and sun exposure score. Participants were aged 5.5 months to 16.0 years (75 males, 83 females). Both treatment groups achieved vitamin D sufficiency. The daily treatment group had significantly higher 25(OH)D levels at each visit post baseline and a higher proportion of participants with levels above 50 nmol/L at all time points. Time, treatment group, calcium and sun exposure score were significant predictors of 25(OH)D serum levels. Depot vitamin D therapy is an alternative to daily treatment in this at-risk group of children and adolescents in whom treatment adherence is problematic.

Keywords: daily; depot; refugee; rickets; supplementation; therapy; vitamin D.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
CONSORT flow diagram.
Figure 3
Figure 3
Mean 25(OH)D (nmol/L) change over time for Daily and Depot Treatment Groups. Raw mean 25(OH)D nmol/L change over time. -- represents threshold level 50 nmol/L -- represents threshold level 78 nmol/L * p < 0.05; **p < 0.01; *** p < 0.001.
Figure 4
Figure 4
Typical dietary vitamin D and calcium intakes in (a) African; (b) Middle-Eastern and (c) Asian families. (Arrows indicate the actual intake, while vertical lines represent the recommended daily intake). DGE empfehlung = German Nutrition Society (DGE) recommendation
Figure 5
Figure 5
Generalized Linear Mixed Models (GLMM) Model 1 Predicted mean 25(OH)D nmol/L change over time; - - 50 nmol/L threshold - - 78 nmol/L threshold.

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