ISRCTN ISRCTN29617677
DOI https://doi.org/10.1186/ISRCTN29617677
Secondary identifying numbers NTR476
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
13/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.A.E. van Bokhorst - de van der Schueren
Scientific

VU University Medical Center
Department of Nutrition and Dietetics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Email m.vanbokhorst@vumc.nl

Study information

Study designRandomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMalnutrition
InterventionUsual nutritional care versus oral nutritional supplements (600 kcal/day) from admission to hospital until 3 months after discharge.
Intervention typeOther
Primary outcome measure1. 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 measuresChanges in body weight, body composition
Overall study start date01/01/2006
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants164
Key inclusion criteria1. 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
Key exclusion criteria1. Well-nourished
2. Decreased consciousness
3. Inability to speak the Dutch language
4. Expected length of hospital stay <2 days
Date of first enrolment01/01/2006
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 10/02/2010 Yes No
Results article results 01/05/2011 Yes No
Results article results 01/12/2012 Yes No