- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057914
Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.
November 6, 2020 updated by: Uppsala University
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.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
671
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dalarna
-
Falun, Dalarna, Sweden, 79129
- Falu Lasarett
-
-
Sörmland
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Eskilstuna, Sörmland, Sweden, 61188
- Mälarsjukhuset in Eskilstuna
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Nyköping, Sörmland, Sweden, 61188
- Nyköpings lasarett
-
-
Uppland
-
Uppsala, Uppland, Sweden, 75125
- Akademiska Sjukhuset
-
-
Västmanland
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Västerås, Västmanland, Sweden, 72189
- Vastmanlands Sjukhus Vasteras
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Experimental: Supplemention
|
The patient consumes 400 kcal from a liquid supplementation formula
|
Experimental: Dietary advice
|
The patient receives dietary advice for one hour during the hospital stay.
|
Experimental: Combination treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality
Time Frame: Six months, one year, three years
|
Six months, one year, three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health-related quality of life
Time Frame: Six months, one year, three years
|
Six months, one year, three years
|
Health-care consumption
Time Frame: Six months, one year, three years
|
Six months, one year, three years
|
Function in activities in daily life
Time Frame: Six months, one year, three years
|
Six months, one year, three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Leif Bergkvist, Centre for clinical research, Landstinget Västmanland/Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
January 27, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (Estimate)
January 28, 2010
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTV-69151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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