An observational study in Inflammatory Bowel Disease, Crohn Disease and Ulcerative Colitis, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 5 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Boston Children's Hospital · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 50 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.
Exclusion Criteria:
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.
Also known as: cholecalciferol
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
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
Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
parathyroid hormone
assessing parathyroid hormone
Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
serum safety parameter
evaluate serum calcium level
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
c-reactive protein
evaluating c-reactive protein
Time frame: 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
Time frame: 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
Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
baseline questionnaire on overall health
assess overall health questionnaire
Time frame: at 0 weeks (entry into study)
fracture history questionnaire
assess fracture history
Time frame: at 0 weeks (entry into study)
food frequency questionnaire
assess calcium and vitamin D food frequency
Time frame: at 0 weeks (entry into study)
physical activity questionnaire
assess physical activity level
Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
sun exposure questionnaire
assess sunlight exposure
Time frame: 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
Time frame: at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)
Plan to share: No
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