- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02010762
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease (DETECT)
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear promising but are hampered by immunogenicity, side effects and high cost.
Vitamin D has recently received a lot of scientific attention and was found to have strong anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally missed its endpoint because of lack of power.
The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in the prevention of postoperative recurrence.
Panoramica dello studio
Descrizione dettagliata
Our objective is to study the prophylactic effect of Vitamin D3 to prevent post-operative recurrence of Crohn's disease (CD), with an endoscopic endpoint 6 months after surgery as the primary outcome. Endoscopy has been an established surrogate marker for future clinical relapse. Secondary objectives include clinical recurrence rates at 6 months, the difference in recurrence rates among patients with and without low Vitamin D levels at baseline, the effects of Vitamin D3 on quality of life parameters, resource use and related costs.
ANTICIPATED OUTCOME This study will provide proof of the anti-inflammatory effect of vitamin D, which to our opinion can best be studied in a post-operative setting. Since post-operative recurrence is frequent, a safe and cost-effective therapy is highly needed for this indication. The hypothesis is that patients who receive vitamin D treatment will have less frequent and less severe endoscopic recurrence.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Amsterdam, Olanda, 1105 BK
- Academic Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age ≥ 18 years, either male or female
- Established CD
- First or second ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
- Able to give written informed consent
- Normal levels of serum calcium at inclusion
- Being able to resume oral intake within 2 weeks after surgery
Exclusion Criteria:
- Patients in whom not all visible CD has been resected
- Active fistulizing perianal disease (requiring anti TNF treatment)
- Extensive small bowel resection
- Third, fourth or later ileocolonic resection
- Patients undergoing ileocoecal resection in the Lir!c Trial (NTR 1150, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1150)
- A history of primary hyperparathyroidism
- A history of osteoporosis for which calcium and Vitamin D treatment are mandatory
- A history of another granulomatous diseases (sarcoidosis, tuberculosis)
- Pregnant or breastfeeding (at index date) female patients
- Patients undergoing other resections than ileocolonic resections
- Patients who prefer to use open-label vitamin D preparations
- Patients who will continue to use tanning beds
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Vitamin D
Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection
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25.000 IU oral drops
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Comparatore placebo: Placebo
Weekly placebo drops for 6 months following ileocoecal resection
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placebo oral drops
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Lasso di tempo: 0-6 months
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0-6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
Lasso di tempo: 0-6 months
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0-6 months
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2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
Lasso di tempo: 0-6 months
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0-6 months
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3. Difference in significant recurrence among all patients with low vitamin D at baseline
Lasso di tempo: 0-6 months
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0-6 months
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4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
Lasso di tempo: 0-6 months
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0-6 months
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5. Any adverse events
Lasso di tempo: 0-6 months
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0-6 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Geert D'Haens, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NL.45391.018.13
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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