Iron and Vitamin Supplementation in Hip/Knee Surgery

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Completed

Conditions: Anemia; Orthopedic Disorder; Hip Arthropathy; Iron Poor Blood; Knee Arthropathy

Treatments: Dietary Supplement: Iron plus folic acid, vitamin B2, B6, B12, C, and E

Study type: Interventional

Funder types: Other

Identifiers

NCT04880499

L4143 (Other Grant/Funding Number)

EMA-IRON (PI: M Briguglio)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Intervention (group A)

Experimental group

Description:

Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care.

Treatment:

Dietary Supplement: Iron plus folic acid, vitamin B2, B6, B12, C, and E

Control (group B)

No Intervention group

Description:

Patients who are not subjected to the intervention and follow the standard of care.