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

Recruiting

• Conditions: Vitamin D Deficiency; Ulcerative Colitis; Inflammatory Bowel Disease; Crohn Disease

• Registration Number: NCT04331639
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Study Start: 2020-11-01
• Primary Completion: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
baseline questionnaire on overall health	at 0 weeks (entry into study)	assess overall health questionnaire
food frequency questionnaire	at 0 weeks (entry into study)	assess calcium and vitamin D food frequency
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
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
physical activity questionnaire	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)	assess physical activity level
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
serum safety parameter	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)	evaluate serum calcium level
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.
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
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
fracture history questionnaire	at 0 weeks (entry into study)	assess fracture history
sun exposure questionnaire	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)	assess sunlight exposure
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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States