Iron and Vitamin Supplementation in Hip/Knee Surgery

Randomized controlled trial to evaluate the efficacy of oral iron supplementation plus cofactors in reducing the prevalence of preoperative anemia in a cohort of 60 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

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Galeazzi

Milan, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Iron plus folic acid, vitamin B2, B6, B12, C, and E

Dietary Supplement

A number of 30 subjects are supplemented with iron plus folic acid, vitamin B2, B6, B12, C, and E daily for 60+/-15 days before orthopedic surgery.

Primary outcomes

Change of blood hemoglobin levels

Time frame: Baseline and 60 days +/- 15 days

Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Emacrit Plus in Prosthetic Hip and Knee Surgery

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 10, 2021
Registry last updated: May 6, 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.

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Completed