Plain-English translation of NCT04331639 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This trial is testing whether high-dose vitamin D3 supplements can help young people (ages 5–25) with inflammatory bowel disease who are already receiving biologic therapy like Infliximab or Vedolizumab. Researchers will give participants the vitamin D supplement at the same time they receive their regular biologic injections every 4–8 weeks, and then measure how it affects bone health and inflammation markers in the blood.
People with inflammatory bowel disease often have low vitamin D levels, which can weaken bones and may worsen inflammation. Researchers want to see if giving this medication alongside biologic therapy can safely improve vitamin D levels and protect bone health in young patients.
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You would take high-dose vitamin D3 by mouth on a scheduled basis while continuing your regular biologic therapy infusions every 4–8 weeks. At your routine clinical visits, the study team will collect extra blood samples to check your vitamin D levels, bone health markers, and inflammation markers. You'll also complete questionnaires about your diet, sun exposure, physical activity, and how you're feeling.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
United States
Sponsor
Boston Children's Hospital
Enrollment target
~50 participants
Started
November 2020
Primary completion
September 2024
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
5 Years – 25 Years
Last updated on clinicaltrials.gov in March 2025.
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Central contact
Rebecca Gordon, MD
Boston Children's Hospital
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