Transmural Nutritional Support
| 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
Scientific
VU University Medical Center
Department of Nutrition and Dietetics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| m.vanbokhorst@vumc.nl |
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
"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
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 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/02/2010 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No | |
| Results article | results | 01/12/2012 | Yes | No |
