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

ISRCTN	ISRCTN69447524
DOI	https://doi.org/10.1186/ISRCTN69447524
Secondary identifying numbers	SEO124

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 05/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tim Trebble
Scientific

Institute of Human Nutrition
Level C
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)23 80 796 317
Email	abc@123.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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 objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2000
Completion date	01/05/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Added December 2008: 61
Key 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.
Key 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.
Date of first enrolment	01/05/2000
Date of final enrolment	01/05/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Human Nutrition

Southampton
SO16 6YD
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on composition and function of circulating mononuclear cells	01/11/2004		Yes	No
Results article	results on the response of bone turnover	01/08/2005		Yes	No

Editorial Notes

05/07/2018: Internal review