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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hip Fractures Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FontActiv Superprotein/Hypercaloric Fiber

Full Nutritional Supplement

Group Type EXPERIMENTAL

FontActiv Superprotein/Hypercaloric Fiber

Intervention Type DIETARY_SUPPLEMENT

The product under study has a liquid presentation, in 200 ml bottles, ready to take

Carbohydrates and C Vitamin

Nutritional Supplement

Group Type ACTIVE_COMPARATOR

Carbohydrates and C Vitamin

Intervention Type DIETARY_SUPPLEMENT

The control product will be prepared with equal presentation and taste as similar as possible tan study product

Interventions

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FontActiv Superprotein/Hypercaloric Fiber

The product under study has a liquid presentation, in 200 ml bottles, ready to take

Intervention Type DIETARY_SUPPLEMENT

Carbohydrates and C Vitamin

The control product will be prepared with equal presentation and taste as similar as possible tan study product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No