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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Other: Combination of supplement and dietary advice; Dietary Supplement: Nutritional supplementation with a liquid formula; Other: Dietary advice

• Registration Number: NCT01057914
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-02
• Status Verified: 2020-11
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Combination treatment	Combination of supplement and dietary advice	-
Supplemention	Nutritional supplementation with a liquid formula	-
Dietary advice	Dietary advice	-

Primary Outcome Measures

Name	Time	Method
All cause mortality	Six months, one year, three years

Secondary Outcome Measures

Name	Time	Method
Health-care consumption	Six months, one year, three years
Health-related quality of life	Six months, one year, three years
Function in activities in daily life	Six months, one year, three years

Trial Locations

Locations (5)

Falu lasarett; 🇸🇪 Falun, Dalarna, Sweden

Mälarsjukhuset in Eskilstuna; 🇸🇪 Eskilstuna, Sörmland, Sweden

Nyköpings lasarett; 🇸🇪 Nyköping, Sörmland, Sweden

Akademiska sjukhuset; 🇸🇪 Uppsala, Uppland, Sweden

Västmanlands sjukhus Västerås; 🇸🇪 Västerås, Västmanland, Sweden