The major goal of the study was to see how beneficial a single high-dose of oral vitamin D3 was in children with inflammatory bowel disease (IBD) and hypovitaminosis D. The secondary goal of this study was to look at the safety of stoss therapy. A randomized, prospective trial of 44 individuals with IBD with 25-hydroxyvitamin D values of 30 ng/mL was undertaken. Patients were randomly assigned to receive either 50,000 IU of vitamin D3 once a week for six weeks or 300,000 IU once. Serum 25-OHD levels were measured at baseline, four and twelve weeks. Week 4 saw the completion of safety monitoring labs. The trial was completed by 39 of the 44 participants that were recruited. The groups’ baseline vitamin D levels did not differ substantially. Stoss treatment resulted in a significant increase in 25-OHD levels at week 4, which was comparable to the weekly regimen. At week 12, serum 25-OHD levels fell in both groups, with the stoss group considerably lower, but still close to 30 ng/mL. Over time, there was a substantial interaction with the therapy group. All patients who received stoss treatment had normal serum calcium and PTH levels at week 4. Stoss treatment was favored by 80% of patients over the weekly regimen.
Stoss treatment was equally safe and effective as the weekly regimen in increasing 25-OHD in children with IBD.