High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04331639

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis Vitamin D Deficiency	Dietary Supplement: vitamin D3	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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