Sucrosomial vs Intravenous Iron for Anemia
(RSIVI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether oral sucrosomial iron is as effective as intravenous (IV) iron in treating anemia (low red blood cell count) before heart surgery. Participants will either take iron capsules or receive iron through an IV to determine which method more effectively boosts their red blood cell count. The trial seeks individuals diagnosed with anemia, scheduled for heart surgery, and with low but not critically low hemoglobin levels on a recent test. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.
What is the safety track record for intravenous and sucrosomial iron treatments?
Research has shown that sucrosomial iron is generally easy for the body to handle. In a study with patients who had anemia, this iron supplement improved hemoglobin levels, which are crucial for healthy red blood cells. Importantly, patients did not report any major side effects. Another review supports these findings, highlighting sucrosomial iron as a safe option for managing mild iron deficiency anemia.
Intravenous iron has been used for a long time and is already approved for treating anemia, indicating it is generally safe. Most people handle intravenous iron well, though some might experience mild side effects like headaches or nausea.
Overall, both sucrosomial and intravenous iron have good safety records. Based on existing research, participants in this trial can expect these treatments to be well-tolerated.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Sucrosomial Iron for treating anemia because it offers a convenient oral alternative to traditional intravenous (IV) iron therapies. Unlike IV iron, which requires hospital visits and needle infusions, Sucrosomial Iron is taken as capsules, making it easy and pain-free to use. This form of iron is designed to be more easily absorbed by the body, potentially leading to effective results without the hassle and discomfort of IV administration. This new delivery method could simplify treatment for patients and improve adherence, making it a promising option for those with anemia.
What evidence suggests that this trial's treatments could be effective for anemia?
This trial will compare the effectiveness of sucrosomial iron and intravenous iron in treating anemia. Research has shown that sucrosomial iron effectively treats anemia, with 81% of patients achieving hemoglobin levels of 12 g/dL or higher. On average, these patients experienced an increase in hemoglobin of about 3.6 g/dL. However, sucrosomial iron may not fully restore iron levels in the body, despite improving hemoglobin. Intravenous iron, which participants in this trial may also receive, is a common treatment for anemia and has been proven to effectively increase red blood cell counts. Both treatments offer benefits, but sucrosomial iron provides a promising pill-based alternative to intravenous iron for raising hemoglobin.13678
Who Is on the Research Team?
Michael P Eaton, MD
Principal Investigator
University of Rochester
Are You a Good Fit for This Trial?
This trial is for 50 patients with anemia who are scheduled for heart surgery or procedures. Participants should have a diagnosis of iron-deficiency anemia and be in need of preoperative iron supplementation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intravenous iron infusions or oral sucrosomial iron capsules until the day of surgery
Surgery
Participants undergo their scheduled heart surgery or procedure
Follow-up
Participants are monitored for post-operative complications and recovery
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Iron
- Sucrosomial Iron
Trial Overview
The study is testing if oral sucrosomial iron can increase red blood cell count as effectively as the standard intravenous iron treatment before heart surgery.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.
If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.
In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Pharmanutra S.p.a.
Industry Sponsor
Citations
Sucrosomial® Iron: An Updated Review of Its Clinical Efficacy ...
Most patients (81%) experienced the correction of anemia (Hb ≥ 12 g/dL) at day 60. Similarly, a significant increment was observed in the ...
Sucrosomial® iron effectiveness in recovering from mild ...
Mean Hb increment was 3.6 ± 1.5 g/dL, and 81% of patients achieved Hb levels of ≥ 12 g/dL at the end of the treatment period. These results are ...
Oral iron supplementation: new formulations, old questions
The overall data suggest that sucrosomial® iron improved hemoglobinization but did not always efficiently replenish iron stores. For instance, ...
Preventive Oral Iron Supplementation with Sucrosomial® ...
Results: After 12 weeks, hemoglobin levels remained stable, with ferritin increasing by 49% and TSAT by 58%. No patients required transfusions ...
Oral sucrosomial iron improves exercise capacity and ...
Oral sucrosomial iron improves exercise capacity and quality of life in heart failure with reduced ejection fraction and iron deficiency: a non ...
Preventive Oral Iron Supplementation with Sucrosomial® ...
Conclusions: SI is an effective and well-tolerated option for managing mild IDA in cancer patients, improving iron absorption and reducing the need for ...
Sucrosomial Iron Supplementation in Anemic Patients with ...
After a follow-up of 90 days both groups showed an increase in Hb levels compared to baseline (+10.1% and +16.2% for sucrosomial and sulfate groups, ...
Sucrosomial Vs Intravenous Iron for Preoperative Anemia
Study Overview. 50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of- ...
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