Iron and Vitamin Supplementation in Hip/Knee Surgery
Not Applicable
Completed
- Conditions
- AnemiaIron Poor BloodOrthopedic DisorderHip ArthropathyKnee Arthropathy
- Interventions
- Dietary Supplement: Iron plus folic acid, vitamin B2, B6, B12, C, and E
- Registration Number
- NCT04880499
- Lead Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention (group A) Iron plus folic acid, vitamin B2, B6, B12, C, and E Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.
- Primary Outcome Measures
Name Time Method Change of blood hemoglobin levels Baseline and 60 days +/- 15 days Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Istituto Ortopedico Galeazzi
🇮🇹Milan, Italy