Iron Supplementation in Hip/Knee Surgery

NCT ID: NCT04078880

Last Updated: 2023-05-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-01-01

Brief Summary

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Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.

Detailed Description

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Conditions

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Orthopedic Disorder Hip Arthropathy Knee Arthropathy Anemia Iron Poor Blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention (group A)

Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.

Group Type EXPERIMENTAL

Sucrosomial iron plus ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.

Control (group B)

Patients who are not subjected to the intervention and follow the standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sucrosomial iron plus ascorbic acid

A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males and females
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery

Exclusion Criteria

* ASA 4
* Present or past neuropsychiatric conditions
* Hip or knee revision surgery
* Use of iron as dietary supplement
* Known erythrocytosis
* Incompatible hypersensitivities
* Iron metabolism disorders
* Lymphoproliferative disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Perazzo

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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L2039

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Sideral (PI: P Perazzo)

Identifier Type: -

Identifier Source: org_study_id

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