ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Children with Crohn’s disease may have vitamin D deficiency and a theoretical link between vitamin D levels and relapse risk; this trial tested whether adding high‑dose vitamin D3 at diagnosis could lower relapses and improve quality of life. Results could have informed a simple, low‑cost adjunct if positive.
Who Should Pay Attention
Pediatric patients with Crohn’s disease and their caregivers; pediatric gastroenterologists and IBD clinicians; researchers studying nutritional or adjunctive therapies in IBD.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 3
Enrollment55 participants
Study statusTerminated
Source depthTrial registry record
What To Know
This is a terminated Phase 3 randomized controlled trial (ViDiPeC-2) registered on ClinicalTrials.gov testing high‑dose oral vitamin D3 (3,000–4,000 IU/day with maintenance 2,000 IU/day) as adjunct therapy in children with Crohn’s disease to reduce 52‑week relapse rates and improve quality of life.
Planned primary endpoint was proportion with at least one relapse at 52 weeks; secondary endpoints included QoL scores, cumulative steroid dose, time to first relapse, number of relapses, hospitalizations, and safety outcomes (hypercalcemia, hypercalciuria, supra‑optimal 25OHD3 levels).
Eligibility targeted ages 4–17 with PCDAI ≤10 and stable maintenance immunomodulator or anti‑TNF therapy; planned enrollment was 55. Registry status: TERMINATED.
Keep In Mind
This record is a trial registry entry (Phase 3) and is labeled TERMINATED; the listing describes trial design, planned endpoints, and safety monitoring but does not report results. Because the study did not complete as registered, no efficacy or safety conclusions should be drawn from this record alone.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorJantchou Prevost
Trial IDNCT03999580
Study typeInterventional
Trial phasePhase 3
Enrollment55 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 21, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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