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

NCT ID: NCT01057914

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Keywords

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Randomized controlled trial Malnutrition Aged Aged 80 and over Nutrition therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplemention

Group Type EXPERIMENTAL

Nutritional supplementation with a liquid formula

Intervention Type DIETARY_SUPPLEMENT

The patient consumes 400 kcal from a liquid supplementation formula

Dietary advice

Group Type EXPERIMENTAL

Dietary advice

Intervention Type OTHER

The patient receives dietary advice for one hour during the hospital stay.

Combination treatment

Group Type EXPERIMENTAL

Combination of supplement and dietary advice

Intervention Type OTHER

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.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional supplementation with a liquid formula

The patient consumes 400 kcal from a liquid supplementation formula

Intervention Type DIETARY_SUPPLEMENT

Dietary advice

The patient receives dietary advice for one hour during the hospital stay.

Intervention Type OTHER

Combination of supplement and dietary advice

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Västmanland County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leif Bergkvist

Role: PRINCIPAL_INVESTIGATOR

Centre for clinical research, Landstinget Västmanland/Uppsala University

Locations

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Falu lasarett

Falun, Dalarna County, Sweden

Site Status

Mälarsjukhuset in Eskilstuna

Eskilstuna, Sörmland, Sweden

Site Status

Nyköpings lasarett

Nyköping, Sörmland, Sweden

Site Status

Akademiska sjukhuset

Uppsala, Uppland, Sweden

Site Status

Västmanlands sjukhus Västerås

Västerås, Västmanland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32362168 (View on PubMed)

Other Identifiers

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LTV-69151

Identifier Type: -

Identifier Source: org_study_id