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 |
| Secondary identifying numbers | RDC00898 |
- 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
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
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | 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 study start date | 01/09/1997 |
| Completion date | 01/09/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
St Bartholomew's & Royal London School of Medicine & Dentistry
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (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 | 01/12/2001 | Yes | No |
