Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Tim Trebble


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The effect of combined n-3 polyunsaturated fatty acid and antioxidant dietary supplements on Crohn's disease & the associated osteoporosis, malnutrition and morbidity


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet


Digestive system diseases: Inflammatory bowel disease; Musculoskeletal diseases: Osteoporosis


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



Not Specified

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Human Nutrition
SO16 6YD
United Kingdom

Sponsor information


NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

NHS Executive South East (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2004 results on composition and function of circulating mononuclear cells in
2. 2005 results on the response of bone turnover in

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

05/07/2018: Internal review