| Source of record | UK Trials |
| ISRCTN | ISRCTN01133608 |
| Date ISRCTN assigned | 12/09/2002 |
| Local reference number(s) | 577/484 |
| Public title | A randomised double-blind placebo-controlled study of energy, protein and micronutrients supplementation of elderly patients in active rehabilitation settings |
| Scientific title |
|
| Acronym | FED Trial |
| Disease/condition/study domain | Nutritional status in the elderly |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised double-blind placebo-controlled study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients will be eligible for the study if they meet the following criteria:
1. Age 65 years, stable medical condition, referred for an active rehabilitation program
2. Able to swallow
3. Able to sign an informed written consent form |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 01/01/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Elderly patients referred for an active period of rehabilitation following an episode of acute illness are randomised to:
1. Normal hospital diet plus placebo, or
2. Normal hospital diet plus oral supplements for 6 weeks
Normal diet is what is normally provided to patients. All patients will have nutritional supplements or placebo prescribed in their drug charts. The supplement group will receive a daily oral nutritional supplement 400 ml or more given daily at 15.00 and 20.00 hours in addition to the standard hospital diet. The composition of the supplement is such as to provide between 100 - 150% of the Reference Nutrient Intakes for a healthy old person for the following nutrients: carbohydrates, protein, fat, vitamins (A, C, D, E, B1, B2, B6, B12, folic acid, niacin, biotin and pantothenic acid), and minerals (potassium, magnesium, calcium, phosphorous, chloride, iron, zinc, iodine, copper, manganese and selenium).
Supplementation will continue for a period of 6 weeks. This will be either entirely in hospital or in the community also for patients discharged earlier than 6 weeks. For those discharged earlier than 6 weeks supplies will be given for patients to take in the community and they or their carers will be shown how to fill in food diary cards for the remaining period. The placebo will be identical to the supplement but will contain no protein or micronutrients and with a minimum calorie content in it to make it tasty and palatable to patients. Different flavours of supplements and placebo will be prepared and tested initially in a pilot study and those most liked by patients will be made available for patients to choose from. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Health Foundation (UK) |
| Sponsor name | The Health Foundation (UK) |
| Sponsor details | 90 Long Acre
London
United Kingdom
WC2E 9RA |
| Sponsor telephone | +44 (0)20 7257 8000 |
| Sponsor fax | +44 (0)20 7257 8001 |
| Sponsor email | info@health.org.uk |
| Sponsor website | http://www.pppfoundation.org.uk/ |
| Contact name | Dr SE Gariballa |
| Contact details | Sheffield Institute for Studies on Ageing
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
United Kingdom
S5 7AU |
| Contact telephone | +44 (0)114 271 5124 |
| Contact fax | +44 (0)114 271 5771 |
| Contact email | s.e.gariballa@sheffield.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN01133608 |
| Date last extracted from ISRCTN register | 17/04/2008 |
