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

Boston Children's Hospital50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis Vitamin D Deficiency

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

vitamin D target

assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL

Time frame: at study conclusion, up to 64 weeks

Secondary Outcomes

change in vitamin D level

assess change in serum 25-OHD level from study entry to study conclusion

Time frame: at study conclusion, up to 64 weeks

vitamin D binding protein

assessing vitamin D binding protein and free vitamin D