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.
Items in both categories Infant-Child and Loading Dose are listed here:
- Growing pains reduced in 91% of children with a single dose of Vitamin D – July 2024
- High-dose Vitamin D safe for children (10,000 IU daily, 600,000 IU bolus) – meta-analysis April 2022
- Childhood cancers – give Vitamin D loading dose if low – Oct 2021
- Vitamin D loading dose was as effective as daily dosing (rickets in this case) – RCT July 2021
- 3X less Septic Shock in children with sepsis getting 150,000 IU of Vitamin D - RCT June 2020
- Child soccer players who were deficient were helped by a single 200,000 IU vitamin D dose – RCT May 2020
- Infant Vitamin D doubles 6 months after birth (can double in 2 weeks)– Oct 2019
- Vitamin D levels in children optimized with six Vitamin D biscuits – RCT Nov 2018
- 2X improved development by severely malnourished children with 2 loading doses of vitamin D – RCT May 2018
- 100,000 IU Vitamin D weekly for 4 weeks is safe and effective for children – May 2019
- Vitamin D loading dose of 300,000 IU for children – 3 weeks with capsules, biscuits, injection – RCT Aug 2018
- Critically ill children – randomized clinical trial to give single doses of up to 400,000 IU of vitamin D – 2019
- Childhood asthma problems eliminated for months by 600,000 IU of Vitamin D injection – June 2017
- Quick restoration of vitamin D in children – 10,000 IU per kg loading dose was not enough – Jan 2017
- Takes a year to restore children and youths to good levels of vitamin D without loading dose - RCT Dec 2016
- Children in Intensive Care need Vitamin D loading dose of 10000 IU per kg (nearing a consensus) - Oct 2016
- Newborn Vitamin D - single 50,000 IU is better than daily – RCT Sept 2016
- Pediatric trials of high dose vitamin D -163 are in a single online database – Feb 2016
- Rapid Normalization of Vitamin D in Critically Ill Children (10,000 IU per kg) – clinical trial
- Vitamin D loading doses of up to 400,000 IU OK for adolescents – meta-analysis Dec 2014
- Neonate loading dose of 30,000 IU vitamin D helped a lot – May 2014
- Recurrence of child pneumonia delayed by 100000 IU of vitamin D – RCT Oct 2010
- 600,000 IU of vitamin D2 every 4 months for decades in East Germany – 1987
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
Download the PDF from Sci-Hub via VitaminDWiki
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.