ICCBH2019 Poster Presentations (1) (226 abstracts)
Safety and effectiveness of stoss therapy in children
Melissa Fiscaletti 1 , Paul Tannous 1 , Nicholas Wood 1, , Hasantha Gunasekera 2 , Yvonne Zurynski 3 , Andrew Biggins 1, , Tatjana Kilo 1 , Evan Hayes 4 & Craig Munns 1,
1The Children’s Hospital at Westmead, Westmead, Australia; 2The University of Sydney Children’s Hospital Westmead Clinical School, Sydney, Australia; 3Macquarie University, North Ryde, Australia; 4BIOCeuticals, Alexandria, Australia.
Objectives: Pediatric vitamin D (25-hydroxyvitamin D - 25OHD) deficiency can lead to nutritional rickets and extra-skeletal complications. Compliance with daily therapy can be difficult, making high dose, short-term vitamin D (stoss) therapy attractive to correct vitamin D deficiency. We compared the effectiveness and safety of standard versus stoss therapy in treating childhood 25OHD deficiency.
Study design: Children aged 2–16 years with 25OHD <50 nmol/l were randomized to either standard (5,000 IUdaily for 80 days) or stoss (100,000 IU weekly for 4 weeks) cholecalciferol. Participants underwent evaluation of effectiveness and safety. 25OHD, random spot calcium: creatinine ratio (Ca:Cr) and compliance were measured at 12 weeks.
Results: 151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (IQR: 6–12 years). Baseline 25OHD levels were 26 nmol/L (IQR: 19–35 nmol/l) and 32 nmol/l (IQR: 24–39 nmol/l) in the standard and stoss groups respectively. At 12 weeks, the median 25OHD level was significantly greater in the standard vs stoss group (81 vs 67 nmol/l; P=0.005), however, >80% of participants in both groups achieved sufficiency (25OHD>50 nmol/l) and had normal urinary Ca:Cr, with no significant difference seen between groups. Compliance was similar in the two groups.
Conclusion: Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, there were a similar number of participants with 25OHD sufficiency and safety. Unlike other studies, simplifying the treatment regimen did not improve compliance. These results support stoss therapy as an effective and safe alternative therapy for the treatment of pediatric vitamin D deficiency.
Disclosure: The authors declared no competing interests.
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