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Nutritional Intervention in Hip Fracture Patients

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ClinicalTrials.gov Identifier: NCT00523575
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : July 20, 2011
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Hip Fracture Malnutrition Dietary Supplement: Cubitan

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
Study Start Date : August 2007
Primary Completion Date : December 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: C
Usual nurse and dietetic care
Experimental: I
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Dietary Supplement: Cubitan
400 ml/d
Other Name: Nutricia: Cubitan

Primary Outcome Measures :
  1. Total length of hospital stay and rehabilitation clinics [ Time Frame: baseline, 3 months and 6 months after inclusion ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523575

Atrium MC
Heerlen, Netherlands, 6419 PC
Maastricht University Hospital
Maastricht, Netherlands, 6229 HA
Sittard, Netherlands, 6131 BK
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: P C Dagnelie, PhD Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie
Principal Investigator: P LM Reijven, PhD Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PC Dagnelie, PhD, Maastricht University
ClinicalTrials.gov Identifier: NCT00523575     History of Changes
Other Study ID Numbers: MEC 06-3-098
ZonMw 80-007022-98-07510
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Maastricht University Medical Center:
hip fracture
nutritional support

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Nutrition Disorders
Femoral Fractures
Hip Injuries
Leg Injuries