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

Clinical Trial to Assess the Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Elderly Patients With Spontaneous Hip Fracture

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

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Hip Fractures
• Intervention / Treatment: Dietary supplement: FontActiv Superprotein/Hypercaloric Fiber; Dietary supplement: Carbohydrates and C Vitamin

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Málaga, Andalucía, Spain, 29010
      • Hospital Clínico de Malaga
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FontActiv Superprotein/Hypercaloric Fiber; Full Nutritional Supplement	Dietary supplement: FontActiv Superprotein/Hypercaloric Fiber; The product under study has a liquid presentation, in 200 ml bottles, ready to take
ACTIVE_COMPARATOR: Carbohydrates and C Vitamin; Nutritional Supplement	Dietary supplement: Carbohydrates and C Vitamin; The control product will be prepared with equal presentation and taste as similar as possible tan study product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare changes in nutritional status between groups based on phase angle	Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)	From baseline to month 4
Compare changes in nutritional status between groups based on force measurement	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).	From baseline to month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare functional recovery	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.	From baseline to month 4
To compare the morphological recovery by muscle ultrasound	Compare the morphological recovery valued by muscle ultrasound between patients taking nutritional supplement under study and placebo. Ultrasound performed at baseline and month 4	From baseline to month 4
To compare changes in Mini Nutrition Assessment test for aged people	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.	From baseline to month 4
To compare the evolution of the Global Subjective Valuation questionnaire	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.	From baseline to month 4
Compare changes between groups in the Charlson index	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.	From baseline to month 4
Number of participants that have to be readmitted at the hospital.	Compare the difference in hospital re-admissions between the two study groups.	From baseline to month 4
Number of participants that die during the study	Compare the differences in mortality within four months of the start of the study between the two study groups	From baseline to month 4
Compare changes in the ratio RCP/Prealbumin index in the blood analysis	Compare changes in the ratio RCP/Prealbumin index between the two study groups.	From baseline to month 4

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Investigators: Principal Investigator: Jose Manuel Garcia Almeida, Hospital Clínico de Malaga

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: nutritional supplement; phase angle
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Nutrition Disorders; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: IRENE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No