High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Recruiting · NCT04331639 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boston Children's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
5 Years to 25 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed across 1 US state.
- Boston Children's Hospital - Boston, Massachusetts, United States
- Boston Children's Hospital - Boston, Massachusetts, United States