Safety and effectiveness of stoss therapy in children with vitamin D deficiency

Paul Tannous; Melissa Fiscaletti; Nicholas Wood; Hasantha Gunasekera; Yvonne Zurynski; Andrew Biggin; Tatjana Kilo; Evan Hayes; Craig Munns

doi:10.1111/jpc.14497

Safety and effectiveness of stoss therapy in children with vitamin D deficiency

J Paediatr Child Health. 2020 Jan;56(1):81-89. doi: 10.1111/jpc.14497. Epub 2019 May 28.

Authors

Paul Tannous^{1

2}, Melissa Fiscaletti³, Nicholas Wood^{4

5}, Hasantha Gunasekera⁵, Yvonne Zurynski⁶, Andrew Biggin⁷, Tatjana Kilo⁸, Evan Hayes⁹, Craig Munns⁷

Affiliations

¹ Department of General Paediatrics, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
² School of Medicine Sydney, NSW, University of Notre Dame, Sydney, New South Wales, Australia.
³ Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
⁴ Department of Immunisation Research, The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
⁵ Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.
⁶ Health Systems Sustainability, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.
⁷ Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.
⁸ Department of Haematology, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
⁹ Scientific Advisory Board, FIT-BIOCeuticals, Sydney, New South Wales, Australia.

PMID: 31136042
DOI: 10.1111/jpc.14497

Abstract

Aim: Paediatric 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.

Methods: Children aged 2-16 years with 25OHD <50 nmol/L were randomised to either standard (5000 IU daily for 80 days) or stoss (100 000 IU weekly for 4 weeks) cholecalciferol. Participants underwent an evaluation of effectiveness and safety. The 25OHD level, random spot calcium: creatinine ratio (Ca:Cr) and compliance were measured at 12 weeks.

Results: A total of 151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (inter-quartile range (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 versus 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.

Conclusions: Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity. 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 paediatric vitamin D deficiency.

Keywords: children; stoss; vitamin D deficiency.

Publication types

Randomized Controlled Trial

MeSH terms

Adolescent
Calcifediol
Calcium
Child
Child, Preschool
Cholecalciferol
Humans
Vitamin D
Vitamin D Deficiency* / complications
Vitamin D Deficiency* / drug therapy
Vitamins

Substances

Vitamins
Vitamin D
Cholecalciferol
Calcifediol
Calcium

Grants and funding

Fit Bioceuticals