Nutritional Intervention in Hip Fracture Patients

Malnutrition Clinical Trial

Official title:

Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523575
• Other study ID #: MEC 06-3-098
• Secondary ID: ZonMw 80-007022-
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: July 19, 2011
• Start date: August 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Malnutrition

Intervention

Dietary Supplement:
• Cubitan
400 ml/d

Locations

Country	Name	City	State
Netherlands	Atrium MC	Heerlen
Netherlands	Maastricht University Hospital	Maastricht
Netherlands	Maaslandziekenhuis	Sittard

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total length of hospital stay and rehabilitation clinics		baseline, 3 months and 6 months after inclusion	No
Secondary	Nutritional status, hip functionality, physical disability, fatigue, quality of life.		baseline, 3 months and 6 months after inclusion	No
Secondary	Cost questionnaire, informal care questionnaire.		baseline, 3 months and 6 months after inclusion	No
Secondary	Rate of complications		baseline, 3 months and 6 months after inclusion	No