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NCT04880499 Clinical Trial

Iron and Vitamin Supplementation in Hip/Knee Surgery

Anemia Clinical Trial

Official title:
Emacrit Plus in Prosthetic Hip and Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04880499
Other study ID # EMA-IRON (PI: M Briguglio)
Secondary ID L4143
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date July 8, 2022

Study information
Verified date May 2023
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 8, 2022
Est. primary completion date July 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Iron plus folic acid, vitamin B2, B6, B12, C, and E
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.

Locations
Country Name City State
Italy Istituto Ortopedico Galeazzi Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of blood hemoglobin levels Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days Baseline and 60 days +/- 15 days
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