An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
NCT ID: NCT03882944
Last Updated: 2022-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
310 participants
OBSERVATIONAL
2020-02-20
2022-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subject is considered malnourished, or is at risk for malnutrition
* Subject conforms to the requirements set forth on the study product label.
* Subject has an estimated, or measured, glomerular filtration rate \>30ml/min/1.73m2 (MDRD equation).
* Subject has been elected for hip fracture surgery and is within three days since surgery.
* The study physician determines the subject is fit to participate.
* Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
* After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay \< 15 days.
Exclusion Criteria
* Subject has active cancer and the study physician determines the subject is not suitable for the study.
* Subject has uncontrolled diabetes.
* Subject is known to be allergic or intolerant to any ingredient found in the study product.
* Participation in another study that has not been approved as a concomitant study.
75 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Camprubi, PhD
Role: STUDY_CHAIR
Abbott
Locations
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Hospital de Alcorcón
Alcorcón, , Spain
Complejo Asistencial de Avila
Ávila, , Spain
Hospital Cruz Roja Gijón
Gijón, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Infanta Elena
Huelva, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, , Spain
Complejo Asistencial Universitario de León
León, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen del Puerto
Plasencia, , Spain
Hospital Universitario De Salamanca
Salamanca, , Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Countries
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Other Identifiers
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DA20
Identifier Type: -
Identifier Source: org_study_id
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