PMID- 31136042
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20220531
IS  - 1440-1754 (Electronic)
IS  - 1034-4810 (Linking)
VI  - 56
IP  - 1
DP  - 2020 Jan
TI  - Safety and effectiveness of stoss therapy in children with vitamin D deficiency.
PG  - 81-89
LID - 10.1111/jpc.14497 [doi]
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.
CI  - (c) 2019 Paediatrics and Child Health Division (The Royal Australasian College of 
      Physicians).
FAU - Tannous, Paul
AU  - Tannous P
AUID- ORCID: 0000-0002-6916-7859
AD  - Department of General Paediatrics, Sydney Children's Hospitals Network, Sydney, 
      New South Wales, Australia.
AD  - School of Medicine Sydney, NSW, University of Notre Dame, Sydney, New South 
      Wales, Australia.
FAU - Fiscaletti, Melissa
AU  - Fiscaletti M
AD  - Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, 
      Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
FAU - Wood, Nicholas
AU  - Wood N
AD  - Department of Immunisation Research, The Children's Hospital at Westmead, Sydney 
      Children's Hospitals Network, Sydney, New South Wales, Australia.
AD  - Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New 
      South Wales, Australia.
FAU - Gunasekera, Hasantha
AU  - Gunasekera H
AUID- ORCID: 0000-0003-4900-1277
AD  - Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New 
      South Wales, Australia.
FAU - Zurynski, Yvonne
AU  - Zurynski Y
AD  - Health Systems Sustainability, Australian Institute of Health Innovation, 
      Macquarie University, Sydney, New South Wales, Australia.
FAU - Biggin, Andrew
AU  - Biggin A
AD  - 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.
FAU - Kilo, Tatjana
AU  - Kilo T
AD  - Department of Haematology, The Children's Hospital at Westmead, Sydney, New South 
      Wales, Australia.
FAU - Hayes, Evan
AU  - Hayes E
AD  - Scientific Advisory Board, FIT-BIOCeuticals, Sydney, New South Wales, Australia.
FAU - Munns, Craig
AU  - Munns C
AD  - 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.
LA  - eng
GR  - Fit Bioceuticals/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190528
PL  - Australia
TA  - J Paediatr Child Health
JT  - Journal of paediatrics and child health
JID - 9005421
RN  - 0 (Vitamins)
RN  - 1406-16-2 (Vitamin D)
RN  - 1C6V77QF41 (Cholecalciferol)
RN  - P6YZ13C99Q (Calcifediol)
RN  - SY7Q814VUP (Calcium)
SB  - IM
CIN - J Paediatr Child Health. 2019 Oct;55(10):1288-1289. PMID: 31629389
MH  - Adolescent
MH  - Calcifediol
MH  - Calcium
MH  - Child
MH  - Child, Preschool
MH  - Cholecalciferol
MH  - Humans
MH  - Vitamin D
MH  - *Vitamin D Deficiency/complications/drug therapy
MH  - Vitamins
OTO - NOTNLM
OT  - children
OT  - stoss
OT  - vitamin D deficiency
EDAT- 2019/05/29 06:00
MHDA- 2021/05/15 06:00
CRDT- 2019/05/29 06:00
PHST- 2018/06/29 00:00 [received]
PHST- 2019/04/16 00:00 [revised]
PHST- 2019/04/30 00:00 [accepted]
PHST- 2019/05/29 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2019/05/29 06:00 [entrez]
AID - 10.1111/jpc.14497 [doi]
PST - ppublish
SO  - J Paediatr Child Health. 2020 Jan;56(1):81-89. doi: 10.1111/jpc.14497. Epub 2019 
      May 28.