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100,000 IU Vitamin D weekly for 4 weeks is safe and effective for children – May 2019

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

J Paediatr Child Health. 2019 May 28. doi: 10.1111/jpc.14497.
Tannous P1, Fiscaletti M2, Wood N3,4, Gunasekera H4, Zurynski Y5, Biggin A6, Kilo T7, Hayes E8, Munns C6.

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Items in both categories Infant-Child and Loading Dose are listed here:


The groups were ethnically very different (Letter to editor, Oct 2019)

TREATMENT OF VITAMIN D DEFICIENCY IN CHILDREN_
We read with interest Tannous et al. ‘Safety and effectiveness of stoss therapy in children with vitamin D deficiency’.1

The aims of randomisation are to minimise bias and confounding factors, produce comparable groups and enable probability theory to identify the risk of outcomes being due to chance alone.2 Random number tables were used to assign treatment groups by family. When applied to the small sample size of this cohort, it does not reliably produce groups with comparable baseline characteristics.2

Although P values for baseline characteristics were not reported, differences in ethnicity were observed (Middle Eastern background represented 24% standard vs. 42% stoss group). This poor spread may result in other unidentified risk factors for vitamin D deficiency and response to treatment such as diet, sunlight exposure and genetic factors. A better spread of covariates may have been achieved through stratified block randomisation.2

A statistical difference in median baseline 25OHD was observed between standard and stoss (26 vs. 32, respectively). This could have been addressed in two ways. Either as the outcome to compare (using t‐test), or fitting a generalised linear model to adjust for baseline differences and other confounders. The global consensus statement3 would stratify the standard as ‘insufficiency’ in 25OHD and the stoss as ‘deficiency’, and does not provide guidelines on dosages for patients with ‘insufficiency’.3 Australian National Consensus statement and state guidelines recommend a reduced dose for insufficiency, which was not applied to this cohort.4

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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.

Created by admin. Last Modification: Monday October 21, 2019 08:46:03 GMT-0000 by admin. (Version 7)

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12128 100,000 weekly.jpg admin 14 Jun, 2019 13:20 56.77 Kb 68
12127 10.1111@jpc.14497.pdf PDF 2019 admin 14 Jun, 2019 13:20 1.05 Mb 30
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