An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
1 other identifier
observational
310
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedStudy Start
First participant enrolled
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2022
CompletedJune 27, 2022
June 1, 2022
1.8 years
March 6, 2019
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Nutritional Status
Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition
Baseline to Week 12
Secondary Outcomes (4)
Barthel Index of Activities of Daily Living
Baseline to Week 12
Functional Ambulation Classification Scale (FAC)
Baseline to Week 12
Short Physical Performance Battery (SPPB)
Week 12
Compliance with Nutritional Supplement
Baseline to Week 12
Other Outcomes (8)
Blood Chemistries - Chemistry Profile
Baseline to Week 12
Blood Chemistries - Hematology Profile
Baseline to Week 12
Blood Chemistries - Lipid Panel
Baseline to Week 12
- +5 more other outcomes
Eligibility Criteria
The study population will include older men and women who are free living (outpatient) or residing in a nursing home, who meet all enrollment criteria. Subjects will be recruited by the investigator(s) from each study site.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (17)
Hospital de Alcorcón
Alcorcón, 28922, Spain
Complejo Asistencial de Avila
Ávila, 50003, Spain
Hospital Cruz Roja Gijón
Gijón, 33202, Spain
Hospital Universitario de Guadalajara
Guadalajara, 19002, Spain
Hospital Infanta Elena
Huelva, 21080, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, 35010, Spain
Complejo Asistencial Universitario de León
León, 24071, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Virgen del Puerto
Plasencia, 10600, Spain
Hospital Universitario De Salamanca
Salamanca, 37007, Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Camprubi, PhD
Abbott
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 20, 2019
Study Start
February 20, 2020
Primary Completion
December 15, 2021
Study Completion
March 18, 2022
Last Updated
June 27, 2022
Record last verified: 2022-06