An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882944
• Other study ID #: DA20
• Status: Completed
• Start date: February 20, 2020
• Est. completion date: March 18, 2022

Study information

• Verified date: June 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 18, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Malnutrition

Locations

Country	Name	City	State
Spain	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	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Chemistries - Chemistry Profile	Blood chemistries collected per standard of care	Baseline to Week 12
Other	Blood Chemistries - Hematology Profile	Hematology blood chemistries collected per standard of care	Baseline to Week 12
Other	Blood Chemistries - Lipid Panel	Lipid panel blood chemistries collected per standard of care	Baseline to Week 12
Other	Body Mass Index	BMI calculated Weight (kg)/Height (m)2	Baseline to Week 12
Other	Length of Stay in Hospital	Information collected for hospital admission and discharge dates	Week 12
Other	Healthcare provider satisfaction questionnaire	HCP completed questionnaire; 3 to 5 category responses scaled in negative direction	Week 12
Other	Subject satisfaction questionnaire	Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction	Week 12
Other	Medication Use	Medications prescribed	Baseline to Week 12
Primary	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	Barthel Index of Activities of Daily Living	Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction	Baseline to Week 12
Secondary	Functional Ambulation Classification Scale (FAC)	6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation	Baseline to Week 12
Secondary	Short Physical Performance Battery (SPPB)	Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction	Week 12
Secondary	Compliance with Nutritional Supplement	Subject completed consumption dairy	Baseline to Week 12