Hohenheim Malnutrition Study in Geriatric Fracture Patients

NCT ID: NCT03493100

Last Updated: 2018-10-26

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-15

Study Completion Date

2018-10-25

Brief Summary

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The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.

Detailed Description

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Conditions

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Geriatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral nutritional supplementation

This group receives optimized nutritional support, by ONS for a period of four weeks.

Group Type EXPERIMENTAL

oral nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.

Control

The control group will receive treatment according to usual care.

Group Type OTHER

Usual care

Intervention Type OTHER

The control group will receive treatment according to usual care.

Interventions

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oral nutritional supplementation

The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.

Intervention Type DIETARY_SUPPLEMENT

Usual care

The control group will receive treatment according to usual care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥ 75 years, or
* age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
* written informed consent

Exclusion Criteria

* progressive cancer disease
* relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
* insufficient German speech intelligibility
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan C. Bischoff

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Locations

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University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HohMal2

Identifier Type: -

Identifier Source: org_study_id

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