Crohn Disease, Inflammatory Bowel Disease, Ulcerative Colitis, Vitamin D Deficiency
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTvitamin 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.
Sponsors
Boston Children's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vitamin D target | at study conclusion, up to 64 weeks | assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vitamin D binding protein | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | assessing vitamin D binding protein and free vitamin D |
| parathyroid hormone | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | assessing parathyroid hormone |
| serum safety parameter | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | evaluate serum calcium level |
| urine safety parameter | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | evaluate urinary calcium to creatinine ratio |
| bone mineral density | at study conclusion, up to 64 weeks, when clinically available | assess changes in bone density and body composition as assessed by DXA scan, when clinically available |
| markers of bone turnover | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | 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. |
| inflammatory bowel disease treatment parameters | at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) | assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available |
| cytokine measurements | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | 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. |
| change in vitamin D level | at study conclusion, up to 64 weeks | assess change in serum 25-OHD level from study entry to study conclusion |
| 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 | evaluating erythrocyte sedimentation rate |
| health-related quality of life questionnaire for inflammatory bowel disease | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | assess quality of life measures in children with inflammatory bowel disease |
| baseline questionnaire on overall health | at 0 weeks (entry into study) | assess overall health questionnaire |
| fracture history questionnaire | at 0 weeks (entry into study) | assess fracture history |
| food frequency questionnaire | at 0 weeks (entry into study) | assess calcium and vitamin D food frequency |
| physical activity questionnaire | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | assess physical activity level |
| sun exposure questionnaire | at 0 weeks (entry into study) and up to 64 weeks (at study conclusion) | assess sunlight exposure |
| follow-up questionnaire on overall health | at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks) | assess for any changes in inflammatory bowel disease treatment since last visit |
| 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 | evaluating c-reactive protein |
Countries
United States
Contacts
Primary ContactRebecca Gordon, MD
Outcome results
None listed