High-dose vitamin D with biologic therapy in inflammatory bowel disease
Gives high-dose vitamin D3 to people with Crohn disease or ulcerative colitis receiving infusions.
Plain-language title generated from the registry record
Registry title: High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Key facts
- Where
- Boston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 25 years old?
Source: NCT04331639, who can take part
Where in United States
- Boston Children's HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boston Children's Hospital
- Trial code
- NCT04331639
- Record updated
- 3 March 2025
- Original description
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.Read full original descriptionShow less
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
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.
Inclusion: 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: Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix; History of any underlying kidney disease; History of preexisting liver disease; History of granulomatous disease; History of hypercalcemia or hypercalciuria; Inability to take oral vitamin D3 as a pill.