Transmural Nutritional Support

ISRCTN	ISRCTN29617677
DOI	https://doi.org/10.1186/ISRCTN29617677
Protocol serial number	NTR476
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Malnutrition
Intervention	Usual nutritional care versus oral nutritional supplements (600 kcal/day) from admission to hospital until 3 months after discharge.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Changes in body weight, body composition
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	164
Key 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
Key exclusion criteria	1. Well-nourished 2. Decreased consciousness 3. Inability to speak the Dutch language 4. Expected length of hospital stay <2 days
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2009

VU University Medical Center

Amsterdam
1007 MB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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