Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-04-21
2022-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention (group A)
Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.
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.
Control (group B)
Patients who are not subjected to the intervention and follow the standard of care.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery
Exclusion Criteria
* 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
60 Years
ALL
Yes
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Principal Investigators
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Matteo Briguglio
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Ortopedico Galeazzi
Locations
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Istituto Ortopedico Galeazzi
Milan, , Italy
Countries
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Other Identifiers
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L4143
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EMA-IRON (PI: M Briguglio)
Identifier Type: -
Identifier Source: org_study_id
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