Actively Recruiting

Age: 5Years - 25Years
All Genders
NCT04331639

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

Led by Boston Children's Hospital · Updated on 2025-03-03

50

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Existing diagnosis of inflammatory bowel disease, including Crohn disease, ulcerative colitis, or indeterminate colitis
  • Receiving treatment with Infliximab or Vedolizumab every 4 to 8 weeks
  • Age between 5 and 25 years at study entry
  • Serum 25-hydroxyvitamin D level less than 40 ng/mL measured within the last 4 to 8 weeks with no changes in vitamin D supplementation during that time
Not Eligible

You will not qualify if you...

  • History of any kidney disease
  • History of preexisting liver disease
  • History of granulomatous disease
  • Unable to take oral vitamin D3 as a pill
  • History of hypercalcemia or hypercalciuria
  • Currently or within the past 3 months taking anti-epileptic medication or Lasix

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

R

Rebecca Gordon, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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