NCT01057914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
671

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

10.8 years

First QC Date

January 27, 2010

Last Update Submit

November 6, 2020

Conditions

Malnutrition

Keywords

Randomized controlled trialMalnutritionAgedAged 80 and overNutrition therapy

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Six months, one year, three years

Secondary Outcomes (3)

  • Health-related quality of life

    Six months, one year, three years

  • Health-care consumption

    Six months, one year, three years

  • Function in activities in daily life

    Six months, one year, three years

Study Arms (4)

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

Interventions

Nutritional supplementation with a liquid formulaDIETARY_SUPPLEMENT

The patient consumes 400 kcal from a liquid supplementation formula

Supplemention
Dietary adviceOTHER

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

Dietary advice
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.

Combination treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Falu lasarett

Falun, Dalarna County, 79129, Sweden

Location

Mälarsjukhuset in Eskilstuna

Eskilstuna, Sörmland, 61188, Sweden

Location

Nyköpings lasarett

Nyköping, Sörmland, 61188, Sweden

Location

Akademiska sjukhuset

Uppsala, Uppland, 75125, Sweden

Location

Västmanlands sjukhus Västerås

Västerås, Västmanland County, 72189, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 32362168DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary SupplementsNutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Leif Bergkvist

    Centre for clinical research, Landstinget Västmanland/Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

SE(5)