Inflammatory Bowel Disease
Conditions
Interventions
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 a
Sponsors
New Care
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in incidence of infection between the 2 intervention groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Infections per organ, postponement or discontinuation with the IBD therapy, hospitalization and exacerbation of IBD | — |
Contacts
Public ContactAnnelijn Heil
Elisabeth-TweeSteden Ziekenhuis
Outcome results
None listed