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
82 participants
INTERVENTIONAL
2018-12-04
2020-01-01
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
TREATMENT
DOUBLE
Study Groups
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Intervention (group A)
Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.
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.
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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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.
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
18 Years
80 Years
ALL
No
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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Paolo Perazzo
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Ortopedico Galeazzi
Locations
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IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Countries
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Other Identifiers
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L2039
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Sideral (PI: P Perazzo)
Identifier Type: -
Identifier Source: org_study_id
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