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Biologic Therapy

High-Dose Vitamin D for Inflammatory Bowel Disease

Phase 2

Recruiting

Led By Rebecca Gordon, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis

Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

Awards & highlights

Study Summary

This trial will be testing the effects of high doses of vitamin D given concurrently with biologic therapy for inflammatory bowel disease.

Who is the study for?

This trial is for young people aged 5-25 with Inflammatory Bowel Disease (IBD) like Crohn's or ulcerative colitis, who are on biologic therapies Infliximab or Vedolizumab. They must have low vitamin D levels without recent changes in supplements and no kidney, liver diseases, granulomatous disease, high calcium issues, or certain medications.Check my eligibility

What is being tested?

The study tests if taking high doses of vitamin D at the same time as biologic treatments for IBD helps patients. It involves extra blood tests and questionnaires during their regular infusion appointments to monitor effects.See study design

What are the potential side effects?

Potential side effects may include elevated calcium levels which can lead to kidney stones or bone pain. However, since it's a vitamin supplement being tested rather than a drug, fewer side effects are expected compared to typical medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with inflammatory bowel disease (IBD).

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I am on Infliximab or Vedolizumab treatment every 4-8 weeks.

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I am between 5 and 25 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

vitamin D target

Secondary outcome measures

baseline questionnaire on overall health

bone mineral density

c-reactive protein

+15 more

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,680 Total Patients Enrolled

Rebecca Gordon, MD5.01 ReviewsPrincipal Investigator - Boston Children's Hospital

Boston Children's Hospital

2 Previous Clinical Trials

128 Total Patients Enrolled

Media Library

Biologic Therapy (Biologic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04331639 — Phase 2

Inflammatory Bowel Disease Research Study Groups:

Inflammatory Bowel Disease Clinical Trial 2023: Biologic Therapy Highlights & Side Effects. Trial Name: NCT04331639 — Phase 2

Biologic Therapy (Biologic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04331639 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of subjects being evaluated in this investigation?

"Affirmative. According to the information residing on clinicaltrials.gov, this study is actively seeking individuals to participate in their trial that began on November 1st 2020 and was most recently updated July 28th 2022. The research team requires 50 people from a single facility for this project."

Answered by AI

Is my profile compatible with the requirements of this clinical trial?

"This medical study seeks to recruit 50 participants between the ages of 5 and 25 who have been diagnosed with ileocolitis. In order to be eligible for inclusion, individuals must also meet two key criteria: They need to be within the given age range at enrollment, and then receive a treatment involving either infliximab or vedolizumab every 4-8 weeks."

Answered by AI

What are the accompanying safety risks of this therapeutic regimen?

"Considering the pre-existing data, our experts at Power assign this treatment a safety rating of 2. This Phase 2 trial has evidence to support its safety but none that suggests efficacy."

Answered by AI

Is this research endeavor currently seeking participants?

"Correct. Clinicaltrials.gov confirms that since its inception on November 1st 2020, this trial has been actively recruiting patients; the planned recruitment of 50 individuals needs to be completed at a single site."

Answered by AI

Is there an age restriction to participation in this medical experiment?

"The inclusionary parameters for this clinical trial stipulate that only individuals aged 5 to 25 are eligible. Those under 18 and over 65 can participate in 144 or 448 separate studies, respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rebecca Gordon 2020. "High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04331639.

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