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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2022-03-18

Brief Summary

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This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
* 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 known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
* 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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Camprubi, PhD

Role: STUDY_CHAIR

Abbott

Locations

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Hospital de Alcorcón

Alcorcón, , Spain

Site Status

Complejo Asistencial de Avila

Ávila, , Spain

Site Status

Hospital Cruz Roja Gijón

Gijón, , Spain

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Hospital Infanta Elena

Huelva, , Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas, , Spain

Site Status

Complejo Asistencial Universitario de León

León, , Spain

Site Status

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Virgen del Puerto

Plasencia, , Spain

Site Status

Hospital Universitario De Salamanca

Salamanca, , Spain

Site Status

Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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DA20

Identifier Type: -

Identifier Source: org_study_id

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