High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vitamin D3.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency. Basic parameters: 5 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
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.
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 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.
Primary outcome measures
- vitamin D target [Time frame: at study conclusion, up to 64 weeks]
Secondary outcome measures (12)
- change in vitamin D level [Time frame: at study conclusion, up to 64 weeks]
- vitamin D binding protein [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- parathyroid hormone [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- serum safety parameter [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- urine safety parameter [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- bone mineral density [Time frame: at study conclusion, up to 64 weeks, when clinically available]
- markers of bone turnover [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- inflammatory bowel disease treatment parameters [Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- cytokine measurements [Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
- 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 [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 [Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Publications
- 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. PMID 41921771
Identifiers
NCT: NCT04331639 · P00033424