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

Boston Children's Hospital

Status and phase: Enrolling; Phase 2

Conditions: Vitamin D Deficiency; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease

Treatments: Dietary Supplement: vitamin D3

Study type: Observational

Funder types: Other

Identifiers

NCT04331639

P00033424

Details and patient eligibility

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.

Full description

The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

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