Orthopedic DisorderNCT04880499
Iron and Vitamin Supplementation in Hip/Knee Surgery
A study testing Iron plus folic acid, vitamin B2, B6, B12, C, and E in people with Orthopedic Disorder and Hip Arthropathy, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy
- What is being tested?
- Iron plus folic acid, vitamin B2, B6, B12, C, and E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2021to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- ASA 1, 2, or 3
- No neuropsychiatric conditions
- Acceptance of informed consent
- Elective prosthetic hip or knee surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Emacrit Plus in Prosthetic Hip and Knee Surgery
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
- Being tested
- Iron plus folic acid, vitamin B2, B6, B12, C, and E
- Medical subject headings
- Musculoskeletal Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron plus folic acid, vitamin B2, B6, B12, C, and EDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (group A) | Experimental | Patients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood hemoglobin levels
Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days
Measured: Baseline and 60 days +/- 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start21 Apr 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Briguglio, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880499
- Sponsor's protocol ID
- EMA-IRON (PI: M Briguglio)
- Other IDs
- L4143
- Status last verified
- May 2023
- First submitted
- 5 May 2021
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emacrit Plus in Prosthetic Hip and Knee Surgery
- ClinicalTrials.gov ID
- NCT04880499
- Acronym / sponsor ID
- EMA-IRON (PI: M Briguglio)
- Conditions
- Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (group A) | Experimental | Dietary Supplement: Iron plus folic acid, vitamin B2, B6, B12, C, and EPatients who are subjected to the intervention, being iron plus other cofactors for hematopoiesis, other than the standard of care. |
| Control (group B) | No intervention | –Patients who are not subjected to the intervention and follow the standard of care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females
- ASA 1, 2, or 3
- No neuropsychiatric conditions
- Acceptance of informed consent
- Elective prosthetic hip or knee surgery
Key exclusion criteria (8 listed)
- ASA 4
- Present or past neuropsychiatric conditions
- Hip or knee revision surgery
- Use of iron as dietary supplement
- Known erythrocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron plus folic acid, vitamin B2, B6, B12, C, and EA 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. | Dietary supplement | Intervention (group A) |
Primary outcome
Change of blood hemoglobin levels
Time frame: Baseline and 60 days +/- 15 days
Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Briguglio principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron plus folic acid, vitamin B2, B6, B12, C, and E in people with Orthopedic Disorder and Hip Arthropathy, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood hemoglobin levels (time frame: Baseline and 60 days +/- 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.