Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture

Not Applicable

• Conditions: Hip Fractures; Malnutrition
• Interventions: Dietary Supplement: FontActiv Superprotein/Hypercaloric Fiber; Dietary Supplement: Carbohydrates and C Vitamin

• Registration Number: NCT04183075
• Lead Sponsor: Laboratorios Ordesa

Brief Summary

Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.

Detailed Description

Hip fracture is a very prevalent pathology in the elderly population. It is estimated that 35-40% of people over 65 suffer a drop per year, and above 75 years this percentage is even higher, with hip fractures being one of the most serious consequences.With regard to malnutrition, the investigators know that aging carries an increased risk of suffering from decreased appetite and intake and changes in body composition. According to different series, the percentage of malnutrition in patients with hip fracture ranges from 13% to 60%. According to the hospital protocols in Spain in elderly people with spontaneous hip fracture, it is important to perform a nutritional screening during the first 24-48 hours of admission, to evaluate their nutritional status and apply a dietary treatment.

The IRENE study aims to determine whether phase angle and reactance, measured by electrical bioimpedance by vector analysis (BIVA) are related to functional recovery in patients with hip fracture.

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Status Verified: 2020-09
• Study Start: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients over 65 years old.
• Patients admitted to hospital by spontaneous hip fracture and requiring surgery.
• Patients who after hip intervention are included in rehabilitation protocols with outpatient rehabilitation plan.
• Patients who agree to participate by signing informed consent or their regular caregivers grant consent.

Exclusion Criteria

• Patients who have a hip fracture from high-impact trauma or secondary to bone pathology (such as neoplasm).
• Patients with concomitant diseases such as severe hepatic impairment, severe renal impairment, insulin-dependent diabetes melitus and decompensated diabetes mellitus.
• Patients who require clinical stabilization before surgery beyond 72 hours.
• Patients receiving emergency surgery.
• Patients with previous prostheses.
• Patients with pacemakers.
• Patients who are not likely to complete the follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FontActiv Superprotein/Hypercaloric Fiber	FontActiv Superprotein/Hypercaloric Fiber	Full Nutritional Supplement
Carbohydrates and C Vitamin	Carbohydrates and C Vitamin	Nutritional Supplement

Primary Outcome Measures

Name	Time	Method
Compare changes in nutritional status between groups based on phase angle	From baseline to month 4	Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Compare changes in nutritional status between groups based on force measurement	From baseline to month 4	Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).

Secondary Outcome Measures

Name	Time	Method
Compare changes in the ratio RCP/Prealbumin index in the blood analysis	From baseline to month 4	Compare changes in the ratio RCP/Prealbumin index between the two study groups.
To compare the morphological recovery by muscle ultrasound	From baseline to month 4	Compare the morphological recovery valued by muscle ultrasound between patients taking nutritional supplement under study and placebo. Ultrasound performed at baseline and month 4
To compare the evolution of the Global Subjective Valuation questionnaire	From baseline to month 4	To compare the evolution of the Global Subjective Valuation between the two study groups. It is a method designed to estimate nutritional status through medical history and physical examination. Each of the sections is valued as mild, moderate or severe, being severe the worst nutritional condition.
Compare changes between groups in the Charlson index	From baseline to month 4	Charlson index takes into account the number and severity of accompanying diseases to predict the risk of death. Each pathology that patient has, has a number. The higher the number, the worst prediction.
Number of participants that have to be readmitted at the hospital.	From baseline to month 4	Compare the difference in hospital re-admissions between the two study groups.
To compare functional recovery	From baseline to month 4	Compare functional recovery using the Barthel Scale between patients taking nutritional supplement under study and placebo. It is scored on a scale ranging from 0 to 100, with 90 being the maximum score if the patient is in a wheelchair.
Number of participants that die during the study	From baseline to month 4	Compare the differences in mortality within four months of the start of the study between the two study groups
To compare changes in Mini Nutrition Assessment test for aged people	From baseline to month 4	Compare changes in the Mini Nutrition Assessment score between the two study groups. This is a validated test for aged people to assess the nutritional status. Good nutritional state: more than 17points. Bad nutritional state: less than 17 points.

Trial Locations

Locations (2)

Hospital Clínico de Málaga; 🇪🇸 Málaga, Andalucía, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Andalucía, Spain