Iron Supplementation in Hip/Knee Surgery (SID-IRON)

May 8, 2023 updated by: Istituto Ortopedico Galeazzi

Sideral Forte in Prosthetic Hip and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control (group B)
Patients who are not subjected to the intervention and follow the standard of care.
Experimental: Intervention (group A)
Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 30 days +/- 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Paolo Perazzo, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Actual)

September 16, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sideral (PI: P Perazzo)
  • L2039 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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