MalnutritionNCT01057914
Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.
A study testing Nutritional supplementation with a liquid formula, Dietary advice and Combination of supplement and dietary advice in people with Malnutrition, run by Uppsala University at 5 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional supplementation with a liquid formula, Dietary advice and Combination of supplement and dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 5 sitesSweden
- Study dates
- Feb 2010to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years old
- Admitted to one of the participating wards during the recruitment period
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Mälarsjukhuset in Eskilstuna
Eskilstuna, Sörmland, 61188
Falu lasarett
Falun, Dalarna County, 79129
Nyköpings lasarett
Nyköping, Sörmland, 61188
Akademiska sjukhuset
Uppsala, Uppland, 75125
Västmanlands sjukhus Västerås
Västerås, Västmanland County, 72189
About this study
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.
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.
- Conditions
- Malnutrition
- Being tested
- Nutritional supplementation with a liquid formula, Dietary advice, Combination of supplement and dietary advice
- Keywords
- Randomized controlled trial, Malnutrition, Aged, Aged 80 and over, Nutrition therapy
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementation with a liquid formulaDietary supplement
The patient consumes 400 kcal from a liquid supplementation formula
Dietary adviceOther
The patient receives dietary advice for one hour during the hospital stay.
Combination of supplement and dietary adviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplemention | Experimental | Not described Receives: Dietary Supplement: Nutritional supplementation with a liquid formula |
| Dietary advice | Experimental | Not described Receives: Other: Dietary advice |
| Combination treatment | Experimental | Not described Receives: Other: Combination of supplement and dietary advice |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: Six months, one year, three years
Secondary outcomes (3)
Health-related quality of life
Measured: Six months, one year, three years
Health-care consumption
Measured: Six months, one year, three years
Function in activities in daily life
Measured: Six months, one year, three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Leif Bergkvist, Principal investigator, Centre for clinical research, Landstinget Västmanland/Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057914
- Sponsor's protocol ID
- LTV-69151
- Status last verified
- Nov 2020
- First submitted
- 27 Jan 2010
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32362168
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01057914
- Acronym / sponsor ID
- LTV-69151
- Conditions
- Malnutrition
- Keywords
- Randomized controlled trial, Malnutrition, Aged, Aged 80 and over, Nutrition therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Study start
- Feb 2010
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplemention | Experimental | Dietary Supplement: Nutritional supplementation with a liquid formula |
| Dietary advice | Experimental | Other: Dietary advice |
| Combination treatment | Experimental | Other: Combination of supplement and dietary advice |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ≥65 years old
- Admitted to one of the participating wards during the recruitment period
Key exclusion criteria (11 listed)
- Well-nourished
- No consent to participate
- Not able to communicate
- Not able to understand swedish
- Presumed life-expectancy <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementation with a liquid formulaThe patient consumes 400 kcal from a liquid supplementation formula | Dietary supplement | Supplemention |
| Dietary adviceThe patient receives dietary advice for one hour during the hospital stay. | Other | Dietary advice |
| Combination of supplement and dietary adviceThe patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge. | Other | Combination treatment |
Primary outcome
All cause mortality
Time frame: Six months, one year, three years
3 secondary outcomes
Health-related quality of life
Time frame: Six months, one year, three years
Health-care consumption
Time frame: Six months, one year, three years
Function in activities in daily life
Time frame: Six months, one year, three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 32362168Soderstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Bergkvist principal investigator
Centre for clinical research, Landstinget Västmanland/Uppsala University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation with a liquid formula, Dietary advice and Combination of supplement and dietary advice in people with Malnutrition, run by Uppsala University at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Six months, one year, three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.