Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
13/05/2013
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 M.A.E. van Bokhorst - de van der Schueren

ORCID ID

Contact details

VU University Medical Center
Department of Nutrition and Dietetics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
m.vanbokhorst@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR476

Study information

Scientific title

Acronym

Study hypothesis

To study the cost-effectiveness of transmural nutritional support (from admission to hospital until 3 months after discharge) in malnourished elderly patients, compared to usual care.

Ethics approval

Not provided at time of registration

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Malnutrition

Intervention

Usual nutritional care versus oral nutritional supplements (600 kcal/day) from admission to hospital until 3 months after discharge.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Changes in ADL, functional limitations, muscle strength, quality of life
2. Length of hospital stay, number of re-admissions to hospital, complication rate, number of medical prescriptions and number of doctor contacts within the first 3 months after discharge
3. Economic evaluation

Secondary outcome measures

Changes in body weight, body composition

Overall trial start date

01/01/2006

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hospitalised patients of 60 years and over with a BMI <20 and/or involuntary weight loss >10% (= malnourished)
2. Admitted to the departments of internal medicine
3. Gastroenterology
4. Nephrology
5. Rheumatology
6. Dermatology

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

164

Participant exclusion criteria

1. Well-nourished
2. Decreased consciousness
3. Inability to speak the Dutch language
4. Expected length of hospital stay <2 days

Recruitment start date

01/01/2006

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20146794
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21527171
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22658444

Publication citations

  1. Protocol

    Neelemaat F, Thijs A, Seidell JC, Bosmans JE, van Bokhorst-de van der Schueren MA, Study protocol: cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care., Nutr J, 2010, 9, 6, doi: 10.1186/1475-2891-9-6.

  2. Results

    Neelemaat F, Bosmans JE, Thijs A, Seidell JC, van Bokhorst-de van der Schueren MA, Post-discharge nutritional support in malnourished elderly individuals improves functional limitations., J Am Med Dir Assoc, 2011, 12, 4, 295-301, doi: 10.1016/j.jamda.2010.12.005.

  3. Results

    Neelemaat F, van Bokhorst-de van der Schueren MA, Thijs A, Seidell JC, Weijs PJ, Resting energy expenditure in malnourished older patients at hospital admission and three months after discharge: predictive equations versus measurements., Clin Nutr, 2012, 31, 6, 958-966, doi: 10.1016/j.clnu.2012.04.010.

Additional files

Editorial Notes