Contact information
Type
Scientific
Primary contact
Dr SE Gariballa
ORCID ID
Contact details
Sheffield Institute for Studies on Ageing
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5124
s.e.gariballa@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
577/484
Study information
Scientific title
Acronym
FED Trial
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Nutritional supplements
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
445
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
01/01/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Institute for Studies on Ageing
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
The Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16815489
Publication citations
-
Results
Gariballa S, Forster S, Effects of acute-phase response on nutritional status and clinical outcome of hospitalized patients., Nutrition, 22, 7-8, 750-757, doi: 10.1016/j.nut.2006.04.011.