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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01011608 |
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Date of registration:
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10/11/2009 |
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Primary sponsor: |
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Public title:
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Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
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Scientific title:
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Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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127 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01011608 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Anne C Voss, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott Nutrition |
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Key inclusion & exclusion criteria
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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%.
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hip Fracture
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Intervention(s)
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Other: Medical Food Supplement
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Other: standard hospital food
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Primary Outcome(s)
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Blood chemistry
[Time Frame: 28 days]
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Secondary Outcome(s)
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Functionality (pain, mobility, strength)
[Time Frame: 28 days]
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Product intake
[Time Frame: 28 days]
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Surgical site status
[Time Frame: 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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