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Completed

NCT Number: NCT01088139

Nutritional Intervention for Geriatric Hip Fracture Patients

This is a randomized controlled, observer blinded trial to study the beneficial effect of nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D supplementation whereas the intervention group will receive a moderately high dose protein nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the same rehabilitation program and dietary counseling before discharge. They are followed up 4 weeks after discharge or completion of supplementation. The outcome parameters are nutritional parameters and rehabilitation outcomes.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation, Kowloon Hospital

Kowloon, Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 60 years or older
  • Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment

Exclusion criteria

  • Patients who require tube feeding
  • Patients in unstable medical condition
  • Body mass index (BMI) ≧ 25
  • Malignancy
  • Conditions with contraindication for high protein diet
  • Mentally incapacitated and inability to communicate or understand the consent.

Treatment and study plan

Protein supplementation

Dietary Supplement

Ready made protein supplement drinks with approximate protein content of 18-24g per 500ml per day. Caloric content is 490 to 530Kcal depending on the brand of drink.

Other names: Ensure (Abbott), Resource Breeze (Nestle Nutrition), Compleat (Nestle Nutrition), Glucerna (Abbott)

Primary outcomes

  1. Nutritional parameters

    Time frame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge

    Biochemical and anthropometric measurements

Secondary outcomes

  1. Rehabilitation Outcomes

    Time frame: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge

    functional, strength and mobility measurements

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Completed

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Sponsors and collaborators

Lead sponsor

Kowloon Hospital, Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Mar 17, 2010
Registry last updated
May 4, 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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