Inflammatory Bowel Diseases
Conditions
Brief summary
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.
Detailed description
Monthly supplementation: Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months. Weekly supplementation: Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months. Control: Usual treatment without vitamin D supplementation. All 3 groups: In a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin D supplementation or not.
Interventions
DRUGVitamin D3
24,000 IU cholecalciferol
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment Patient will be recruited by their regularly visit. Patients will be randomly assigned to be supplemented with monthly capsules (monthly group), weekly capsules (weekly group) or no supplementation (control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of Crohn disease or ulcerative colitis
Exclusion criteria
* hypercalcaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fecal calprotectin | every 2 months during 6 months | laboratory disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (OH)-vitamin D serum value | every 2 months during 6 months | serum value cholecalciferol |
Other
| Measure | Time frame | Description |
|---|---|---|
| disease activity score | every 2 months during 6 months | clinical disease activity |
| medication adherence | every 2 months during 6 months | adherence to vitamin D supplementation |
Countries
Switzerland
Outcome results
None listed