Nutritional supplementation and length of stay: a controlled trial of nutritional supplementation in a mixed acute hospital setting

ISRCTN	ISRCTN78277754
DOI	https://doi.org/10.1186/ISRCTN78277754
Protocol serial number	RDC00898
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 11/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeremy Powell-Tuck
Scientific

St Bartholomew's & Royal London School of Medicine & Dentistry
Department of Human Nutrition
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Phone	+44 (0)20 7377 7000 ext 2664

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Key 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.
Key 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
Date of first enrolment	01/09/1997
Date of final enrolment	01/09/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Bartholomew's & Royal London School of Medicine & Dentistry

London
E1 1BB
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	01/12/2001		Yes	No