High Dose Vitamin D3 Supplementation for Children and Young Adults With Inflammatory Bowel Disease Receiving Biologic Therapy

What this Trial Is About

Researchers are evaluating the use of high dose interval oral vitamin D3 supplementation in patients aged 5 to 25 years with inflammatory bowel disease IBD who are receiving biologic therapy such as Infliximab or Vedolizumab every 4 to 8 weeks. This study aims to assess how vitamin D treatment affects bone health and inflammation markers in these patients, alongside measures related to diet, sunlight exposure, physical activity, and overall health. The research is observational and supported by Boston Childrens Hospital. Participants will take high dose vitamin D3 pills at the same time as their biologic treatments, which occur every 4 to 8 weeks. During these scheduled visits, additional blood tests will be collected alongside routine clinical lab work to measure vitamin D levels, bone turnover markers, inflammatory markers, and safety parameters. Questionnaires about dietary vitamin D and calcium intake, physical activity, fracture history, disease activity, sun exposure, and health status will also be completed at various times throughout the study. Participants will be involved for up to 64 weeks, with assessments occurring at the start, midway between 12 and 24 weeks, and at study conclusion. Researchers will monitor vitamin D target levels, inflammatory markers such as c-reactive protein and erythrocyte sedimentation rate, bone mineral density when available, and patient-reported outcomes through questionnaires on quality of life and health. Safety parameters will be tracked through blood and urine tests, and vitamin D binding protein and parathyroid hormone levels will be measured to evaluate treatment effects.

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy