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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Conditions
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Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: vitamin D3|Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D target | assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL | at study conclusion, up to 64 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in vitamin D level | assess change in serum 25-OHD level from study entry to study conclusion | at study conclusion, up to 64 weeks | 
| vitamin D binding protein | assessing vitamin D binding protein and free vitamin D | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| parathyroid hormone | assessing parathyroid hormone | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| serum safety parameter | evaluate serum calcium level | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| urine safety parameter | evaluate urinary calcium to creatinine ratio | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| bone mineral density | assess changes in bone density and body composition as assessed by DXA scan, when clinically available | at study conclusion, up to 64 weeks, when clinically available | 
| markers of bone turnover | evaluating bone turnover markers such as c-telopeptide, bone specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen. May do some of these, and then depending upon the results, consider doing additional analytes, as exploratory analysis. | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| inflammatory bowel disease treatment parameters | assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 
| cytokine measurements | evaluating pro-inflammatory and anti-inflammatory cytokine levels, specifically interleukin-17 and interferon gamma, with likely additional exploratory studies to further characterize immune response to vitamin D repletion depending upon these results. | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | 
| c-reactive protein | evaluating c-reactive protein | at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available | 
| erythrocyte sedimentation rate | evaluating erythrocyte sedimentation rate | at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available | 
| health-related quality of life questionnaire for inflammatory bowel disease | assess quality of life measures in children with inflammatory bowel disease | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | 
| baseline questionnaire on overall health | assess overall health questionnaire | at 0 weeks (entry into study) | 
| fracture history questionnaire | assess fracture history | at 0 weeks (entry into study) | 
| food frequency questionnaire | assess calcium and vitamin D food frequency | at 0 weeks (entry into study) | 
| physical activity questionnaire | assess physical activity level | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | 
| sun exposure questionnaire | assess sunlight exposure | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | 
| follow-up questionnaire on overall health | assess for any changes in inflammatory bowel disease treatment since last visit | at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks) |