Stoss therapy with 300,000 IU of oral vitamin D3 is safe and effective for correcting hypovitaminosis D in children with inflammatory bowel disease (IBD), according to study results published in the Journal of Pediatric Gastroenterology and Nutrition.

In this randomized, prospective, pilot study, 39 children and adolescents aged 6 to 21 years with IBD and hypovitaminosis D were randomly assigned to receive either a weekly oral dose of a 50,000 IU D3 capsule for 6 weeks (standard of care [SOC] group) or a single dose of 300,000 IU (stoss group). Serum 25-hydroxyvitamin D (25(OH)D), a complete metabolic panel, and C-reactive protein (CRP) were collected at baseline. At weeks 4 and 12, complete metabolic panel and serum 25(OH)D were repeated.

As anticipated, levels of 25(OH)D differed over time in each group (P <.0001). From baseline to week 4, researchers observed a substantial rise in serum 25(OH)D levels in both the SOC group (from 23.1±3.6 ng/mL to 54.6±17.5 ng/mL) and the stoss group (from 20.4±6.4 ng/mL to 53.6±17.3 ng/mL), but no significant difference occurred.


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At week 12, serum 25(OH)D levels decreased in both the SOC group (40.4±11.9 ng/mL) and the stoss group (29.8±7.1 ng/mL); the difference in group means was significant (P =.04). No patients in either group had serum 25(OH)D levels above toxicity (>150 ng/mL) when tested at week 4 or week 12. Stoss therapy was well-tolerated; almost 80% of patients preferred the stoss therapy to the weekly regimen.

This study was limited by its homogenous sample; a larger multicenter study will provide a more robust and representative patient population. Researchers did not collect data on other possible confounders, including dietary vitamin D intake and exposure to sunlight. This study was not blinded, which could have led to recall bias. Researchers in future studies should consider administering each dose in clinic under direct supervision.

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“One of the major advantages of stoss therapy is that it reduces the treatment burden and perhaps improves adherence because it is only given once,” the researchers concluded. “We recognize that while we have shown stoss therapy can effectively increase vitamin D levels without any signs of hypervitaminosis D, we have not demonstrated the long-term clinical outcomes for hypovitaminosis D in children with IBD. A longitudinal study evaluating vitamin D levels with a higher dose of cholecalciferol and relevant clinical outcomes is required. The majority of patients preferred the concept of stoss therapy to weekly therapy and can be an alternative option for patients with poor compliance.”

Reference

Lee R, Maltz RM, Crandall WV, et al. Single high dose vitamin D3 supplementation in pediatric patients with inflammatory bowel disease and hypovitaminosis D [published online December 18, 2019]. J Pediatr Gastroenterol Nutr. doi:10.1097/MPG.0000000000002590