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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331639
• Other study ID #: P00033424
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Boston Children's Hospital
• Contact: Rebecca Gordon, MD
• Phone: 617-355-7476
• Email: rebecca.gordon[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	vitamin D binding protein	assessing vitamin D binding protein and free vitamin D	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Secondary	parathyroid hormone	assessing parathyroid hormone	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Secondary	serum safety parameter	evaluate serum calcium level	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	baseline questionnaire on overall health	assess overall health questionnaire	at 0 weeks (entry into study)
Secondary	fracture history questionnaire	assess fracture history	at 0 weeks (entry into study)
Secondary	food frequency questionnaire	assess calcium and vitamin D food frequency	at 0 weeks (entry into study)
Secondary	physical activity questionnaire	assess physical activity level	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Secondary	sun exposure questionnaire	assess sunlight exposure	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Secondary	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)