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

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

Research output: Contribution to journalArticleResearchpeer-review

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.

LanguageEnglish
Pages81-89
Number of pages9
JournalJournal of Paediatrics and Child Health
Volume56
Issue number1
Early online date28 May 2019
DOIs
Publication statusPublished - Jan 2020

Fingerprint

Vitamin D Deficiency
Safety
Vitamin D
Therapeutics
Compliance
Pediatrics
Rickets
Complementary Therapies

Keywords

  • children
  • stoss
  • vitamin D deficiency

Cite this

Tannous, Paul ; Fiscaletti, Melissa ; Wood, Nicholas ; Gunesekera, Hasantha ; Zurynski, Yvonne ; Biggin, Andrew ; Kilo, Tatjana ; Hayes, Evan ; Munns, Craig. / Safety and effectiveness of stoss therapy in children with vitamin D deficiency. In: Journal of Paediatrics and Child Health. 2020 ; Vol. 56, No. 1. pp. 81-89.
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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.",
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Tannous, P, Fiscaletti, M, Wood, N, Gunesekera, H, Zurynski, Y, Biggin, A, Kilo, T, Hayes, E & Munns, C 2020, 'Safety and effectiveness of stoss therapy in children with vitamin D deficiency', Journal of Paediatrics and Child Health, vol. 56, no. 1, pp. 81-89. https://doi.org/10.1111/jpc.14497

Safety and effectiveness of stoss therapy in children with vitamin D deficiency. / Tannous, Paul; Fiscaletti, Melissa; Wood, Nicholas; Gunesekera, Hasantha ; Zurynski, Yvonne; Biggin, Andrew ; Kilo, Tatjana; Hayes, Evan ; Munns, Craig.

In: Journal of Paediatrics and Child Health, Vol. 56, No. 1, 01.2020, p. 81-89.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Safety and effectiveness of stoss therapy in children with vitamin D deficiency

AU - Tannous, Paul

AU - Fiscaletti, Melissa

AU - Wood, Nicholas

AU - Gunesekera, Hasantha

AU - Zurynski, Yvonne

AU - Biggin, Andrew

AU - Kilo, Tatjana

AU - Hayes, Evan

AU - Munns, Craig

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N2 - 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.

AB - 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.

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