A randomised double-blind placebo-controlled study of energy, protein and micronutrients supplementation of elderly patients in active rehabilitation settings

ISRCTN	ISRCTN01133608
DOI	https://doi.org/10.1186/ISRCTN01133608
Secondary identifying numbers	577/484

Submission date: 12/09/2002
Registration date: 12/09/2002
Last edited: 08/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr SE Gariballa
Scientific

Sheffield Institute for Studies on Ageing
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 271 5124
Email	s.e.gariballa@sheffield.ac.uk

Study information

Study design	Randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	FED Trial
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional status in the elderly
Intervention	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.
Intervention type	Supplement
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	01/01/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	445
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	01/01/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sheffield Institute for Studies on Ageing

Sheffield
S5 7AU
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Phone	+44 (0)20 7257 8000
Email	info@health.org.uk
Website	http://www.pppfoundation.org.uk/
"ROR"	https://ror.org/02bzj4420

Funders

Funder type

Charity

The Health Foundation (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	01/07/2006		Yes	No