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Vitamin D3 for Inflammatory Bowel Disease (IBD)

Phase 3
Waitlist Available
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. the impact of oral vitamin d administration on calcium excretion will be evaluated during and at the conclusion of this one-year study.
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will test if high doses of Vitamin D3 are safe and effective in treating children and young adults with Inflammatory Bowel Disease.

Eligible Conditions
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will continue to receive oral vitamin d therapy for one year. we will be assessing the efficacy of oral vitamin d therapy, in this dosing schema, to result in 25-oh vitamin d levels during and at the conclusion of this one-year study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will continue to receive oral vitamin d therapy for one year. we will be assessing the efficacy of oral vitamin d therapy, in this dosing schema, to result in 25-oh vitamin d levels during and at the conclusion of this one-year study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
Secondary study objectives
Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vitamin D3 TreatmentExperimental Treatment1 Intervention
Subjects receiving Remicade will be treated with oral Vitamin D3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,681 Total Patients Enrolled

Media Library

Vitamin D3 Clinical Trial Eligibility Overview. Trial Name: NCT03162432 — Phase 3
Inflammatory Bowel Disease Research Study Groups: Vitamin D3 Treatment
Inflammatory Bowel Disease Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT03162432 — Phase 3
Vitamin D3 2023 Treatment Timeline for Medical Study. Trial Name: NCT03162432 — Phase 3
~6 spots leftby Nov 2025
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