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NCT04078880 Clinical Trial

Iron Supplementation in Hip/Knee Surgery

Anemia Clinical Trial

Official title:
Sideral Forte in Prosthetic Hip and Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04078880
Other study ID # Sideral (PI: P Perazzo)
Secondary ID L2039
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date January 1, 2020

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 in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date January 1, 2020
Est. primary completion date September 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
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:
• 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.

Locations
Country Name City State
Italy IRCCS 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 30 days +/- 5 days Baseline and 30 days +/- 5 days
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