Hospital Discharge Oral Nutrition Support Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
To investigate the effect of different strategies for managing malnutrition in the community
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedOctober 7, 2015
October 1, 2015
2.7 years
January 17, 2014
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Nutrient Intake
Measured by 3 day diet diaries and 24 hour recall
12 weeks (8 week intervention followed by 4 week follow up)
Study Arms (3)
ONS 1 and DA
OTHEROral Nutritional Supplement 1 and Dietary Advice
ONS 2 and DA
OTHEROral Nutritional Supplement 2 and Dietary Advice
DA Alone
OTHERDietary Advice Alone
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female
- Age 50 years and over
- Able to eat and drink without the need for altered texture fluids
- Identified at risk of disease related malnutrition
- Competent to provide written informed consent
- Willingness to take part in the study and to follow the study protocol
You may not qualify if:
- Individuals unable to eat or drink
- Chronic renal disease requiring dialysis
- Galactosaemia
- Dysphagia
- Normally or going to be residing in an institution e.g. care home upon discharge from hospital
- Palliative care
- Cancer (active treatment)
- Liver failure
- Poorly controlled diabetes
- Diagnosed lactose intolerance
- Participation in other clinical trials currently or in the previous 4 weeks
- Due to be discharged to an area out of the hospital region
- Requiring tube or parenteral nutrition
- Due to be discharged from hospital on oral nutrition support recommended by a Dietitian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nutricia UK Ltdlead
Study Sites (1)
Nutricia Ltd
Bath, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2014
First Posted
January 31, 2014
Study Start
July 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
October 7, 2015
Record last verified: 2015-10