Multivitamin and mineral supplement for infection in patients with IBD
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NL-OMON24663
- Lead Sponsor
- ew Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
? 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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in incidence of infection between the 2 intervention groups.
- Secondary Outcome Measures
Name Time Method Infections per organ, postponement or discontinuation with the IBD therapy, hospitalization and exacerbation of IBD