Back to resultsIron and Vitamin Supplementation in Hip/Knee Surgery
Primary Purpose
Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Iron plus folic acid, vitamin B2, B6, B12, C, and E
Sponsored by
About this trial
This is an interventional supportive care trial for Orthopedic Disorder
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico Galeazzi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (group A)
Control (group B)
Arm Description
Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.
Patients who are not subjected to the intervention and follow the standard of care.
Outcomes
Primary Outcome Measures
Change of blood hemoglobin levels
Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04880499
Brief Title
Iron and Vitamin Supplementation in Hip/Knee Surgery
Official Title
Emacrit Plus in Prosthetic Hip and Knee Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (group A)
Arm Type
Experimental
Arm Description
Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.
Arm Title
Control (group B)
Arm Type
No Intervention
Arm Description
Patients who are not subjected to the intervention and follow the standard of care.
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron plus folic acid, vitamin B2, B6, B12, C, and E
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of blood hemoglobin levels
Description
Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days
Time Frame
Baseline and 60 days +/- 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Briguglio
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Galeazzi
City
Milan
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Iron and Vitamin Supplementation in Hip/Knee Surgery
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