Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO124
Study information
Scientific title
Acronym
Study hypothesis
Crohn's disease is a chronic inflammatory disease of the bowel, frequently affecting young adults, and occurring in approximately 80 per 100 000 population. Crohn's has many systemic complications, in particular osteoporosis, cachexia, anorexia, all of which contribute to acute and chronic morbidity, frequent hospital admissions and high health costs. Estimates of the annual average costs of treating one Crohn's patient vary between £2652 and £5856 depending on local costs. This amounts to between £212160 and £468480 per 100000 population per year.
Effective therapies in Crohn's are currently restricted to immunosuppressants, such as corticosteroids which can themselves be associated with such side effects as osteoporosis. There is, therefore an argent need for safe, effective, maintenance anti-inflammatory interventions.
We propose the first major clinical trials of combined dietary supplements in Crohn's disease hypothesising that n-3 PUFA and antioxidant cosupplementation will:
1. Reduce clinical disease activity in Crohn's and improve quality of life.
2. Modify bone turnover in favour of bone formation.
3. Reduce the systematic inflammatory response (measured by inflammatory markers) and will lead to an increase in dietary intake and improvement in nutritional status.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Digestive system diseases: Inflammatory bowel disease; Musculoskeletal diseases: Osteoporosis
Intervention
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 containing selenium 200 ug (reference nutrient intake [RNI] 75 ug/day) manganese 3 mg (UK intake 5.5 mg/day), vitamin A 450 ug (RNI 700 ug) vitamin E 30 ug (average UK intake 5-7 mg), vitamin C 90 mg (RNI 40 mg).
2. Placebo will consist of 9 capsules containing olive oil and 1 containing sugar. The placebos are indistinguishable from the active treatments.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/05/2000
Overall trial end date
01/05/2002
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added December 2008: 61
Participant 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.
Recruitment start date
01/05/2000
Recruitment end date
01/05/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Human Nutrition
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2004 results on composition and function of circulating mononuclear cells in http://www.ncbi.nlm.nih.gov/pubmed/15531659
2. 2005 results on the response of bone turnover in http://www.ncbi.nlm.nih.gov/pubmed/16115360
Publication citations
-
Results on composition and function of circulating mononuclear cells
Trebble TM, Arden NK, Wootton SA, Calder PC, Mullee MA, Fine DR, Stroud MA, Fish oil and antioxidants alter the composition and function of circulating mononuclear cells in Crohn disease., Am. J. Clin. Nutr., 2004, 80, 5, 1137-1144.
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Results on the response of bone turnover
Trebble TM, Stroud MA, Wootton SA, Calder PC, Fine DR, Mullee MA, Moniz C, Arden NK, High-dose fish oil and antioxidants in Crohn's disease and the response of bone turnover: a randomised controlled trial., Br. J. Nutr., 2005, 94, 2, 253-261.