Supplementation with an over the counter multivitamin and mineral supplement (New Care Multi®) for 24 weeks in the winter and spring can prevent infections in patients with inflammatory bowel disease in remission with immunomodulators or biological…
ID
Bron
Verkorte titel
Aandoening
Inflammatory Bowel Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The difference in incidence of infection between the 2 intervention groups.
Achtergrond van het onderzoek
Rationale: Patients with inflammatory bowel disease treated with immunomodulators or biological therapy, and in particular anti-tumor necrosis factor (anti-TNF) are at increased risk of infections. Malnutrition and vitamin or mineral deficiencies are common among patients with inflammatory bowel disease. The results of various studies have indicate that vitamin deficiencies increase the risk for infections.
Objective: To evaluate the efficacy of an over the counter multivitamin and mineral supplement, compared with an identically in appearance placebo on the incidence of infections in patients with inflammatory bowel disease with a high risk for infection.
Study design: Single-center, randomized, double-blinded, placebo-controlled, clinical trial to evaluate the efficacy of multivitamin and mineral supplement versus placebo on the incidence of infections in patients with Crohn’s disease or ulcerative colitis. Patients will be stratified for disease and then randomly assigned in a 1:1 ratio to receive multivitamin and mineral supplement or placebo.
Doel van het onderzoek
Supplementation with an over the counter multivitamin and mineral supplement (New Care Multi®) for 24 weeks in the winter and spring can prevent infections in patients with inflammatory bowel disease in remission with immunomodulators or biological therapy.
Onderzoeksopzet
Week 0, 12 and 24
Onderzoeksproduct en/of interventie
Group A will receive an over the counter multivitamin and mineral supplement (New Care Multi®), once daily for the period of 24 weeks.
Group B will be randomized to receive the placebo, identical in appearance, for the same period of follow up.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients between the ages of 18 and 75 years old.
Patients diagnosed with Crohn’s disease or Ulcerative Colitis.
Patients using immunomodulators (azathiopurine, mercaptopurine and thioguanine) and/ or anti-TNF therapy (infliximab, adalimumab, golimumab).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with active inflammation. Disease has to be in remission defined as CRP ≤ 10mg/l, leucocytes between 4.0-10.0 10E9/l and feces calprotectin levels of ≤ 100μg/g.
Patients whose laboratory values not within the reference ranges ; chemistry panel, renal function, hepatic function, vitamin B12 and albumin, including but not limited to hemoglobin, iron (> 8μmol/L) and folic acid levels (> 9nmol/L).
Patients who used vitamin supplements, antibiotics or Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) in the 4 weeks prior to the screening visit, or are planning to do so during the study period.
Patients who are pregnant, lactating or planning pregnancy while enrolled in the study. (The investigational product contains caffeine which can be harmful for the unborn and newborn child.)
Patients who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject’s safety or confound data interpretation.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9410 |
| Ander register | METC Brabant : P1939 |