Hospital Discharge Oral Nutrition Support Trial | NCT02051777

Studies
Hospital Discharge Oral Nutrition Support Trial

NCT02051777

Sponsor

Nutricia UK Ltd

Status

Completed

Last Update Posted

Oct 7, 2015Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Malnutrition

Interventions

Oral Nutritional Supplement 1
Oral Nutritional Supplement 2
Dietary Advice

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 17, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Jan 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2015

Last Update Posted Date

Oct 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONS 1 and DA	Other	Oral Nutritional Supplement 1 and Dietary Advice	Dietary Supplement: Oral Nutritional Supplement 1 Dietary Supplement: Dietary Advice
ONS 2 and DA	Other	Oral Nutritional Supplement 2 and Dietary Advice	Dietary Supplement: Oral Nutritional Supplement 2 Dietary Supplement: Dietary Advice
DA Alone	Other	Dietary Advice Alone	Dietary Supplement: Dietary Advice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Nutritional Supplement 1	Dietary Supplement	Containing macro and micronutrients	ONS 1 and DA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nutrient Intake	Measured by 3 day diet diaries and 24 hour recall	12 weeks (8 week intervention followed by 4 week follow up)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided