Iron Supplementation in Hip/Knee Surgery

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.

Completed

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Key information

Conditions

Orthopedic Disorder Anemia Hematologic Diseases Hemic and Lymphatic Diseases Hip Arthropathy Iron Poor Blood Knee Arthropathy Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucrosomial iron plus ascorbic acid

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.

Primary outcomes

Change of blood hemoglobin levels

Time frame: Baseline and 30 days +/- 5 days

CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Sideral Forte in Prosthetic Hip and Knee Surgery

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Sep 6, 2019
Registry last updated: May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed