RecruitingNCT04331639

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

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


Sponsor

Boston Children's Hospital

Enrollment

50 participants

Start Date

Nov 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving high doses of vitamin D at scheduled intervals helps maintain better vitamin D levels in children and young adults with inflammatory bowel disease (IBD — Crohn's disease or ulcerative colitis) who are already receiving biologic (IV) therapy. Many IBD patients have low vitamin D, and researchers want to know if this approach can safely correct it. **You may be eligible if...** - You are between 5 and 25 years old - You have a diagnosis of IBD (Crohn's disease, ulcerative colitis, or indeterminate colitis) - You are currently receiving infliximab or vedolizumab infusions every 4–8 weeks - Your vitamin D level (25-OHD) was below 40 ng/mL in the last 4–8 weeks **You may NOT be eligible if...** - You have kidney disease, liver disease, or a granulomatous disease (like sarcoidosis) - You have a history of high calcium levels - You cannot swallow a vitamin D pill - You are currently taking anti-seizure medications or the diuretic furosemide (Lasix) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTvitamin 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(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT04331639


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