- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880499
Iron and Vitamin Supplementation in Hip/Knee Surgery
May 4, 2023 updated by: Istituto Ortopedico Galeazzi
Emacrit Plus in Prosthetic Hip and 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Milan, Italy
- Istituto Ortopedico Galeazzi
-
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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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention (group A)
Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.
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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.
|
No Intervention: Control (group B)
Patients who are not subjected to the intervention and follow the standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 60 days +/- 15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matteo Briguglio, 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)
April 21, 2021
Primary Completion (Actual)
July 8, 2022
Study Completion (Actual)
July 8, 2022
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
May 5, 2021
First Posted (Actual)
May 10, 2021
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMA-IRON (PI: M Briguglio)
- L4143 (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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