Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00898
Study information
Scientific title
Acronym
Study hypothesis
Loss of weight and low body weight expressed as a function of height are both common among patients admitted to hospital. A pilot study has shown that about 30% of patients admitted as emergencies to the Royal London Hospital have biochemically demonstrable B vitamin deficiencies. Several studies have demonstrated the relationship between length of hospital stay, morbidity, mortality and such indices of nutritional status, but it is unclear to what extent this relationship is causal. The principal purpose of this study is to examine the effect of two strategic nutritional interventions in a large number of non-elective admissions to the Royal London Hospital on length of stay and mortality. We propose a randomized placebo controlled trial of early dietary supplementation with a palatable liquid oral sip feed and/or water soluble vitamins. In this study we have the opportunity further to document nutritional status among such patients and to develop techniques for rapid determination of water soluble vitamin status.
Ethics approval
Not provided at time of registration
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Other symptoms and general pathology
Intervention
1. Palatable liquid oral sip feed with vitamin supplements
2. Placebo (palatable liquid oral sip feed only)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. It is expected that a significant incidence of biochemical water soluble vitamin deficiency will be detected among the patients admitted via accident and emergency and that HPLC of single blood samples, will provide a reliable method for assay, and prove much more rapid and convenient than the established enzymatic methods of routine screening.
2. The incident of protein/energy malnutrition detected by anthropometric assessment is expected to approximate 40% in the study group of patients.
3. Previous studies suggest that we might expect a reduction of length of stay as a result of feed supplementation of undernourished inpatients. We might also see reductions in mortality in this group.
4. We might detect a reduction in length of stay and mortality as a result of water soluble vitamin supplementation, either in the study population as a whole, or within subgroups identified in the course of the study.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1997
Overall trial end date
01/09/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients admitted acutely to general medicine, general surgery and orthopaedics.
2. Patients with a body mass index <22 within the above sample, will be randomized to oral sipfeed or placebo feed, independent of whether they are receiving vitamin supplements.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Planned admission to medical or orthopaedic wards or to wards other than those 15 taking part in the study.
2. Less than 18 years
3. Mental illness
4. Admission for only 2 days
Recruitment start date
01/09/1997
Recruitment end date
01/09/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Bartholomew's & Royal London School of Medicine & Dentistry
London
E1 1BB
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11884000
Publication citations
-
Results
Vlaming S, Biehler A, Hennessey EM, Jamieson CP, Chattophadhyay S, Obeid OA, Archer C, Farrell A, Durman K, Warrington S, Powell-Tuck J, Should the food intake of patients admitted to acute hospital services be routinely supplemented? A randomized placebo controlled trial., Clin Nutr, 2001, 20, 6, 517-526, doi: 10.1054/clnu.2001.0486.