No registrations found.
ID
Source
Brief title
Health condition
Inflammatory Bowel Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in incidence of infection between the 2 intervention groups.
Secondary outcome
Infections per organ, postponement or discontinuation with the IBD therapy, hospitalization and exacerbation of IBD
Background summary
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.
Study objective
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.
Study design
Week 0, 12 and 24
Intervention
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.
Inclusion criteria
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).
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9410 |
| Other | METC Brabant : P1939 |