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.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in incidence of infections
measured by preformatted questionnaire and clinical data between the
multivitamin and mineral and placebo group.
Secondary outcome
The secondary endpoints of the study are the differences in quality of live
indicated by the Inflammatory Bowel Disease Questionnaire, in fatigue as
measured by the Chalder Fatigue Questionnaire, stool frequency and -
consistency measured by the Bristol Stool Scale and disease activity measured
by standard clinical and laboratory assessments.
Background summary
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.
Study 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.
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.
Study burden and risks
Participants will be asked to fill out the above mentioned questionnaires as
indicated by the table of assessments at the start of the study and at each
regular outpatient clinic visit at 12 and 24 weeks. Furthermore, daily practice
laboratory assessments will be collected during the study, as being part of the
regular outpatient clinic visits of the patients. Multivitamin and minerals
supplement side effects, if they occur, tend to be very mild.
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Listed location countries
Age
Inclusion criteria
* Patients between the ages of 18 and 75 years old;
* Patients diagnosed with Crohn*s disease or Ulcerative Colitis;
* Patients using immunomodulators and/ or biologic therapy.
Exclusion criteria
- patients with active inflammation;
- patients who has undergone surgical resection or are expected to require
during the stuy
- patients wo are pregnant or planning pregnancy.
Design
Recruitment
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 |
|---|---|
| CCMO | NL71054.028.19 |