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Completed

NCT Number: NCT01057914

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falu lasarett, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional supplementation with a liquid formula

Dietary Supplement

The patient consumes 400 kcal from a liquid supplementation formula

Dietary Advice

Other

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

Combination of supplement and dietary advice

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.

Primary outcomes

  1. All cause mortality

    Time frame: Six months, one year, three years

Secondary outcomes

  1. Health-related quality of life

    Time frame: Six months, one year, three years

  2. Health-care consumption

    Time frame: Six months, one year, three years

  3. Function in activities in daily life

    Time frame: Six months, one year, three years

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Västmanland County Council, Sweden

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2010
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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