RODIN – CD: A Randomized Controlled Trial of High Dose Vitamin D Therapy in Crohn’s Disease (RODIN-CD)
Shail Govani, Peter Higgins
There is emerging evidence to support the importance of the role of vitamin D in autoimmune diseases. There is a well-known north-south gradient with respect to the incidence of Crohn’s disease, with more cases farther from the equator. This ecological finding is believed to be mediated through UV-induced production of vitamin D. Among patients with Crohn’s, retrospective studies have shown a link between vitamin D levels and severity of disease, with patients with lower levels more likely to undergo surgery. The single prospective study examining Crohn’s related outcomes found a trend towards improved disease activity (based on CDAI) in patients supplemented with 1200 IU of vitamin D3.
In this study, we aim to prospectively study the impact of high dose supplementation (10,000 IU vitamin D3) in Crohn’s patients with vitamin D deficiency. We have selected a composite endpoint of hospitalizations, surgeries, emergency room visits and steroid prescriptions the primary outcome.
In the pilot phase, we plan to follow 50 patients at 4 sites around the country for 1 year with the goal of fine-tuning the protocol for a large study in subsequent years.