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

Primary Purpose

Hip Fractures, Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FontActiv Superprotein/Hypercaloric Fiber
Carbohydrates and C Vitamin
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring phase angle, nutritional supplement

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínico de Málaga
  • Hospital Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FontActiv Superprotein/Hypercaloric Fiber

Carbohydrates and C Vitamin

Arm Description

Full Nutritional Supplement

Nutritional Supplement

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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.
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
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.
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.
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.
Number of participants that have to be readmitted at the hospital.
Compare the difference in hospital re-admissions between the two study groups.
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
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.

Full Information

First Posted
November 25, 2019
Last Updated
September 17, 2020
Sponsor
Laboratorios Ordesa
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1. Study Identification

Unique Protocol Identification Number
NCT04183075
Brief Title
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
Acronym
IRENE
Official Title
Clinical Trial to Assess the Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Elderly Patients With Spontaneous Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Malnutrition
Keywords
phase angle, nutritional supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FontActiv Superprotein/Hypercaloric Fiber
Arm Type
Experimental
Arm Description
Full Nutritional Supplement
Arm Title
Carbohydrates and C Vitamin
Arm Type
Active Comparator
Arm Description
Nutritional Supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
FontActiv Superprotein/Hypercaloric Fiber
Intervention Description
The product under study has a liquid presentation, in 200 ml bottles, ready to take
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrates and C Vitamin
Intervention Description
The control product will be prepared with equal presentation and taste as similar as possible tan study product
Primary Outcome Measure Information:
Title
Compare changes in nutritional status between groups based on phase angle
Description
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Time Frame
From baseline to month 4
Title
Compare changes in nutritional status between groups based on force measurement
Description
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).
Time Frame
From baseline to month 4
Secondary Outcome Measure Information:
Title
To compare functional recovery
Description
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.
Time Frame
From baseline to month 4
Title
To compare the morphological recovery by muscle ultrasound
Description
Compare the morphological recovery valued by muscle ultrasound between patients taking nutritional supplement under study and placebo. Ultrasound performed at baseline and month 4
Time Frame
From baseline to month 4
Title
To compare changes in Mini Nutrition Assessment test for aged people
Description
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.
Time Frame
From baseline to month 4
Title
To compare the evolution of the Global Subjective Valuation questionnaire
Description
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.
Time Frame
From baseline to month 4
Title
Compare changes between groups in the Charlson index
Description
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.
Time Frame
From baseline to month 4
Title
Number of participants that have to be readmitted at the hospital.
Description
Compare the difference in hospital re-admissions between the two study groups.
Time Frame
From baseline to month 4
Title
Number of participants that die during the study
Description
Compare the differences in mortality within four months of the start of the study between the two study groups
Time Frame
From baseline to month 4
Title
Compare changes in the ratio RCP/Prealbumin index in the blood analysis
Description
Compare changes in the ratio RCP/Prealbumin index between the two study groups.
Time Frame
From baseline to month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roser De Castellar, MD
Phone
+34 902105243
Email
RDeCastellar@ordesa.es
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Vidal, PhD
Phone
+34 935 516 072
Email
svidal@grandfontaine.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Garcia Almeida
Organizational Affiliation
Hospital Clínico de Málaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico de Málaga
City
Málaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Garcia Almeida
Phone
951 03 20 00
Facility Name
Hospital Virgen del Rocío
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Pablo Garcia Luna
Phone
955 01 20 00

12. IPD Sharing Statement

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

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