Hohenheim Malnutrition Study in Geriatric Fracture Patients (HohMal2)

University of Hohenheim

Status: Completed

Conditions: Geriatric Patients

Treatments: Other: Usual care; Dietary Supplement: oral nutritional supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03493100

HohMal2

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

oral nutritional supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: oral nutritional supplementation

Control

Other group

Description:

The control group will receive treatment according to usual care.

Treatment:

Other: Usual care