Iron and Vitamin Supplementation in Hip/Knee Surgery

NCT04880499 | Completed

• 2 other identifiers: EMA-IRON (PI: M Briguglio)L4143
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change of blood hemoglobin levels

  Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days

  Baseline and 60 days +/- 15 days

Study Arms (2)

Intervention (group A)

EXPERIMENTAL

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

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

Control (group B)

NO INTERVENTION

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

Interventions

Iron plus folic acid, vitamin B2, B6, B12, C, and E DIETARY_SUPPLEMENT

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.

Intervention (group A)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• ASA 1, 2, or 3
• No neuropsychiatric conditions
• Acceptance of informed consent
• Elective prosthetic hip or knee surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Anemia

Interventions

Iron; Folic Acid; Riboflavin; Vitamin B 12

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Flavins; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Matteo Briguglio

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: April 21, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

IT (1)