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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Dietary Supplement | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Gordon, MD | Contact | 617-355-7476 | rebecca.gordon@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gordon, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41921771 | Derived | Gordon RJ, Vishwanath V, Lavoie A, Mishra R, Rufo PA. Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease. J Pediatr. 2026 Jul;294:115084. doi: 10.1016/j.jpeds.2026.115084. Epub 2026 Mar 30. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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) |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |