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
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
-
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.
-
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.
-
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.