Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jeremy Powell-Tuck

ORCID ID

Contact details

St Bartholomew's & Royal London School of Medicine & Dentistry
Department of Human Nutrition
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 7377 7000 ext 2664

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes