NCT04078880

Brief Summary

Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

September 2, 2019

Last Update Submit

May 8, 2023

Conditions

Orthopedic DisorderHip ArthropathyKnee ArthropathyAnemiaIron Poor Blood

Outcome Measures

Primary Outcomes (1)

  • Change of blood hemoglobin levels

    CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days

    Baseline and 30 days +/- 5 days

Study Arms (2)

Intervention (group A)

EXPERIMENTAL

Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.

Dietary Supplement: Sucrosomial iron plus ascorbic acid

Control (group B)

NO INTERVENTION

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

Interventions

Sucrosomial iron plus ascorbic acidDIETARY_SUPPLEMENT

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.

Intervention (group A)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesAnemia

Interventions

sucrosomial ironAscorbic Acid

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Paolo Perazzo

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 6, 2019

Study Start

December 4, 2018

Primary Completion

September 16, 2019

Study Completion

January 1, 2020

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

IT(1)