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 |
| Protocol serial number | SEO124 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- 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
Scientific
Institute of Human Nutrition
Level C
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 80 796 317 |
|---|---|
| abc@123.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Biochemical markers of bone turnover (osteocalcin and deoxypridinoline) |
| Completion date | 01/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Institute of Human Nutrition
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
