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Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nutritional supplementation with a liquid formula
Dietary advice
Combination of supplement and dietary advice
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Randomized controlled trial, Malnutrition, Aged, Aged 80 and over, Nutrition therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥65 years old
  • Admitted to one of the participating wards during the recruitment period

Exclusion Criteria:

  • Well-nourished
  • No consent to participate
  • Not able to communicate
  • Not able to understand swedish
  • Presumed life-expectancy <1 year
  • Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
  • Dietary restrictions due to illness or disease inconsistent with the intervention
  • Impaired cognitive function or dementia
  • Body mass index ≥35
  • Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
  • Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Sites / Locations

  • Falu lasarett
  • Mälarsjukhuset in Eskilstuna
  • Nyköpings lasarett
  • Akademiska sjukhuset
  • Västmanlands sjukhus Västerås

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Supplemention

Dietary advice

Combination treatment

Usual care

Arm Description

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Health-related quality of life
Health-care consumption
Function in activities in daily life

Full Information

First Posted
January 27, 2010
Last Updated
November 6, 2020
Sponsor
Uppsala University
Collaborators
Västmanland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01057914
Brief Title
Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.
Official Title
Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Västmanland County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Randomized controlled trial, Malnutrition, Aged, Aged 80 and over, Nutrition therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
671 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplemention
Arm Type
Experimental
Arm Title
Dietary advice
Arm Type
Experimental
Arm Title
Combination treatment
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplementation with a liquid formula
Intervention Description
The patient consumes 400 kcal from a liquid supplementation formula
Intervention Type
Other
Intervention Name(s)
Dietary advice
Intervention Description
The patient receives dietary advice for one hour during the hospital stay.
Intervention Type
Other
Intervention Name(s)
Combination of supplement and dietary advice
Intervention Description
The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
Six months, one year, three years
Secondary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
Six months, one year, three years
Title
Health-care consumption
Time Frame
Six months, one year, three years
Title
Function in activities in daily life
Time Frame
Six months, one year, three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥65 years old Admitted to one of the participating wards during the recruitment period Exclusion Criteria: Well-nourished No consent to participate Not able to communicate Not able to understand swedish Presumed life-expectancy <1 year Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition Dietary restrictions due to illness or disease inconsistent with the intervention Impaired cognitive function or dementia Body mass index ≥35 Living in old peoples homes, sheltered housing, institution, service flats or nursing homes Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Bergkvist
Organizational Affiliation
Centre for clinical research, Landstinget Västmanland/Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Falu lasarett
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79129
Country
Sweden
Facility Name
Mälarsjukhuset in Eskilstuna
City
Eskilstuna
State/Province
Sörmland
ZIP/Postal Code
61188
Country
Sweden
Facility Name
Nyköpings lasarett
City
Nyköping
State/Province
Sörmland
ZIP/Postal Code
61188
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75125
Country
Sweden
Facility Name
Västmanlands sjukhus Västerås
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72189
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32362168
Citation
Soderstrom L, Rosenblad A, Bergkvist L, Frid H, Thors Adolfsson E. Dietary advice and oral nutritional supplements do not increase survival in older malnourished adults: a multicentre randomised controlled trial. Ups J Med Sci. 2020 Aug;125(3):240-249. doi: 10.1080/03009734.2020.1751752. Epub 2020 May 2.
Results Reference
derived

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Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

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