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

Launched by BOSTON CHILDREN'S HOSPITAL · Mar 31, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of high-dose vitamin D supplements in patients with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. The researchers want to see if giving vitamin D alongside standard treatments (like Infliximab or Vedolizumab) helps improve health for those who have low levels of vitamin D. To participate, you need to be between 5 and 25 years old, have a diagnosis of IBD, and have low vitamin D levels (less than 40 ng/mL) recently measured.

If you join the trial, you will take vitamin D pills during your regular treatment visits, and the team will collect some blood samples and fill out questionnaires to monitor your health. It's important to know that this study is not for everyone; for example, if you have kidney or liver disease, can't take pills, or have taken certain medications recently, you may not be eligible. The trial is currently recruiting participants, and it aims to provide valuable insights into how vitamin D might help those with IBD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis
• • Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks
• • Age 5-25 years old, at study entry
• • Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD
• Exclusion Criteria:
• • History of any underlying kidney disease
• • History of preexisting liver disease
• • History of granulomatous disease
• • Inability to take oral vitamin D3 as a pill
• • History of hypercalcemia or hypercalciuria
• • Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix