Clinical trial NCT04331639: High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Official title: Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Crohn Disease
Ulcerative Colitis
Vitamin D Deficiency
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.

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.

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

Primary outcomes:
measure: vitamin D target
timeFrame: at study conclusion, up to 64 weeks
Secondary outcomes:
measure: change in vitamin D level
timeFrame: at study conclusion, up to 64 weeks
measure: vitamin D binding protein
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: parathyroid hormone
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: serum safety parameter
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: urine safety parameter
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: bone mineral density
timeFrame: at study conclusion, up to 64 weeks, when clinically available
measure: markers of bone turnover
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: inflammatory bowel disease treatment parameters
timeFrame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
measure: cytokine measurements
timeFrame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
measure: c-reactive protein
timeFrame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
measure: erythrocyte sedimentation rate
timeFrame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
measure: health-related quality of life questionnaire for inflammatory bowel disease
timeFrame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
measure: baseline questionnaire on overall health
timeFrame: at 0 weeks (entry into study)
measure: fracture history questionnaire
timeFrame: at 0 weeks (entry into study)
measure: food frequency questionnaire
timeFrame: at 0 weeks (entry into study)
measure: physical activity questionnaire
timeFrame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
measure: sun exposure questionnaire
timeFrame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
measure: follow-up questionnaire on overall health
timeFrame: at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rebecca Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References: