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The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease (DETECT)

6. december 2017 opdateret af: Geert D'Haens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

142

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Amsterdam, Holland, 1105 BK
        • Academic Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Vitamin D
Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection
Medicin: Vitamin D
25.000 IU oral drops
Placebo komparator: Placebo
Weekly placebo drops for 6 months following ileocoecal resection
Medicin: Placebo
placebo oral drops

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Tidsramme: 0-6 months
0-6 months

Sekundære resultatmål

Resultatmål
Tidsramme
1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
Tidsramme: 0-6 months
0-6 months
2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
Tidsramme: 0-6 months
0-6 months
3. Difference in significant recurrence among all patients with low vitamin D at baseline
Tidsramme: 0-6 months
0-6 months
4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
Tidsramme: 0-6 months
0-6 months
5. Any adverse events
Tidsramme: 0-6 months
0-6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Efterforskere

  • Ledende efterforsker: Geert D'Haens, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2013

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

10. december 2013

Først indsendt, der opfyldte QC-kriterier

10. december 2013

Først opslået (Skøn)

13. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL.45391.018.13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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