Orthopedic DisorderNCT04078880
Iron Supplementation in Hip/Knee Surgery
A study testing Sucrosomial iron plus ascorbic acid 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 in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy
- What is being tested?
- Sucrosomial iron plus ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2018to 1 Jan 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- 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: Sideral Forte in Prosthetic Hip and Knee Surgery
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.
- Conditions
- Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood
- Being tested
- Sucrosomial iron plus ascorbic acid
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (group A) | Experimental | Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care. Receives: 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. |
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 30 days +/- 5 days
Measured: Baseline and 30 days +/- 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start4 Dec 2018
- Primary completion16 Sep 2019
- Study completion1 Jan 2020
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 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
- Paolo Perazzo, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078880
- Sponsor's protocol ID
- Sideral (PI: P Perazzo)
- Other IDs
- L2039
- Status last verified
- May 2023
- First submitted
- 2 Sep 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sideral Forte in Prosthetic Hip and Knee Surgery
- ClinicalTrials.gov ID
- NCT04078880
- Acronym / sponsor ID
- Sideral (PI: P Perazzo)
- Conditions
- Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Sep 2019 (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 in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.
Study design
- Primary purpose
- Treatment
- 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: Sucrosomial iron plus ascorbic acidPatients who are subjected to the intervention, being iron plus ascorbic acid, 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
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Sucrosomial iron plus ascorbic acidA 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. | Dietary supplement | Intervention (group A) |
Primary outcome
Change of blood hemoglobin levels
Time frame: Baseline and 30 days +/- 5 days
CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 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 9 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.
Paolo Perazzo 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 Sucrosomial iron plus ascorbic acid 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 9 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 30 days +/- 5 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 9 May 2023.