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ClinicalTrials.gov ID

NCT04183075

Lead Sponsor

Laboratorios OrdesaINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

82Estimated

Last Update Posted

Sep 18, 2020Actual

Start Date

Sep 2020Estimated

Primary Completion Date

May 2021Estimated

Completion Date

May 2021Estimated

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

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.

• Hip Fractures
• Malnutrition

• FontActiv Superprotein/Hypercaloric Fiber
• Carbohydrates and C Vitamin

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Laboratorios OrdesaINDUSTRY

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