Digestive system diseases: Inflammatory bowel disease
Conditions
Interventions
1. The dietary intervention consists of: 9 capsules per day of (Maxepa) fish oil (1.62 g of eicosapentaenoic acid, 1.08 g of docosahexanoic acid) and 1 capsule per day of antioxidant vitamins containi
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged between 18 and 75, with a diagnosis of Crohn's disease based on endoscopic, histological or radiological investigation. Patients will be: 1. At high risk of active disease based biochemical markers (i.e. a C-reactive protein [CRP] >6.9 or erythrocyte sedimentation rate [ESR] >20) and history (disease relapse within the last 2 years with Crohn's Disease Activity Index [CDAI] >150). 2. Currently in remission and not requiring use of oral or intravenous steroids or other immunosuppression (with the exception of azathioprine) within the last month.
Exclusion criteria
Exclusion criteria: Patients with no evidence of recurrent disease following bowel resection; patients with other bone disorders e.g. hyperparathyroidism; or use of therapeutic agents known to affect bone metabolism, e.g. hormone replacement therapy (HRT), bisphosphonates, calcium and vitamin D supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of disease remission, as defined by an absence of disease relapses (recognised quantitative increase in Crohn's disease activity index (CDAI) score of 100 to an absolute value of greater than 150) during the 6 month intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical markers of bone turnover (osteocalcin and deoxypridinoline) 2. Markers of inflammation (1L-1, 1L-6 and TNF-a) 3. Quality of life score 4. Nutritional status | — |
Countries
United Kingdom
Outcome results
None listed