Nutritional Intervention in Hip Fracture Patients

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Malnutrition; Hip Fracture

Treatments: Dietary Supplement: Cubitan

Study type: Interventional

Funder types: Other

Identifiers

NCT00523575

MEC 06-3-098

ZonMw 80-007022-98-07510

Details and patient eligibility

About

Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:

1. Does nutritional intervention reduce total length-of-stay?
2. Is nutritional intervention cost-effective?
3. Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?

Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.

Enrollment: 210 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission to one of the participating hospitals because of a proximal femur fracture
• Age 55 years and older

Exclusion criteria

• Periprosthetic or pathologic fracture
• Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
• Life expectation of less than one year due to underlying disease (e.g. cancer)
• Presence of dementia or other severely impaired cognitive function
• Inability to communicate in Dutch language
• Nutritional intervention prior to admission
• Patients who are bedridden
• Patients who are too ill or for any other reason not able to participate adequately in follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

C

No Intervention group

Description:

Usual nurse and dietetic care

I

Experimental group

Description:

Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.

Treatment:

Dietary Supplement: Cubitan