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OpenTrials
Completed

NCT Number: NCT00523575

Nutritional Intervention in Hip Fracture Patients

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.

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Key information

Conditions

Hip Fracture Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium MC, Heerlen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cubitan

Dietary Supplement

400 ml/d

Other names: Nutricia: Cubitan

Primary outcomes

  1. Total length of hospital stay and rehabilitation clinics

    Time frame: baseline, 3 months and 6 months after inclusion

Secondary outcomes

  1. Nutritional status, hip functionality, physical disability, fatigue, quality of life.

    Time frame: baseline, 3 months and 6 months after inclusion

  2. Cost questionnaire, informal care questionnaire.

    Time frame: baseline, 3 months and 6 months after inclusion

  3. Rate of complications

    Time frame: baseline, 3 months and 6 months after inclusion

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 31, 2007
Registry last updated
Jul 20, 2011

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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