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Completed

NCT Number: NCT01011608

Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery

The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regional Clinical Hospital #1, Krasnodar, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is > 45 years of age.
  • Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
  • Subject plans to undergo hip fracture surgery.
  • Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
  • Subject has admission total protein ≤ 70 g/L.
  • Subject has screening serum albumin ≤ 38 g/L.

Exclusion criteria

  • Subject is known to be allergic or intolerant to any ingredient found in the study product.
  • Subject has pre-planned surgery other than hip fracture surgery during the study period.
  • Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
  • Subject has active malignancy
  • Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • Subject has diagnosis of IDDM.
  • Subject has uncontrolled NIDDM determined by HbA1c > 8%.

Treatment and study plan

Medical Food Supplement

Other

Medical Food Supplement to be given in divided portions in morning, afternoon and evening

standard hospital food

Other

standard hospital diet ad. lib.

Primary outcomes

  1. Blood chemistry

    Time frame: 28 days

Secondary outcomes

  1. Product intake

    Time frame: 28 days

  2. Functionality (pain, mobility, strength)

    Time frame: 28 days

  3. Surgical site status

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 11, 2009
Registry last updated
Apr 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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