Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tim Trebble

ORCID ID

Contact details

Institute of Human Nutrition
Level C
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 80 796 317

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes