Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Who is this study for? Patients with Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
What treatments are being studied? Vitamin D3
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Observational
SUMMARY
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 25
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Rebecca Gordon, MD
rebecca.gordon@childrens.harvard.edu
617-355-7476
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital