Clinical trial NCT04183075: Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Malnutrition
Keywords: phase angle
nutritional supplement
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Compare changes in nutritional status between groups based on phase angle
timeFrame: From baseline to month 4
measure: Compare changes in nutritional status between groups based on force measurement
timeFrame: From baseline to month 4
Secondary outcomes:
measure: To compare functional recovery
timeFrame: From baseline to month 4
measure: To compare the morphological recovery by muscle ultrasound
timeFrame: From baseline to month 4
measure: To compare changes in Mini Nutrition Assessment test for aged people
timeFrame: From baseline to month 4
measure: To compare the evolution of the Global Subjective Valuation questionnaire
timeFrame: From baseline to month 4
measure: Compare changes between groups in the Charlson index
timeFrame: From baseline to month 4
measure: Number of participants that have to be readmitted at the hospital.
timeFrame: From baseline to month 4
measure: Number of participants that die during the study
timeFrame: From baseline to month 4
measure: Compare changes in the ratio RCP/Prealbumin index in the blood analysis
timeFrame: From baseline to month 4
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Clínico de Málaga
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
state: Andalucía
Study officials:
affiliation: Hospital Clínico de Málaga
name: Jose Manuel Garcia Almeida
role: PRINCIPAL_INVESTIGATOR
References: