Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia (NCT07556731) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia
Mexico100 participantsStarted 2026-05-01
Plain-language summary
The goal of this study is to compare ferrous salt and liposomal iron for the treatment of iron-deficiency anemia in adult women. The study will also evaluate how well each treatment is tolerated.
The main questions this study aims to answer are:
Does liposomal iron increase hemoglobin levels as effectively as ferrous salt?
Are there differences in side effects, especially gastrointestinal symptoms, between the treatments?
Does dosing ferrous salt every other day improve tolerance compared to daily dosing?
Researchers will compare three oral iron treatment strategies to determine which approach provides the best balance between effectiveness and tolerability.
Participants will:
Be adult women diagnosed with iron-deficiency anemia
Be randomly assigned to one of three groups:
Daily ferrous salt Ferrous salt taken every other day Daily liposomal iron Take the assigned iron treatment for 3 months Have blood tests at the beginning and end of the study to measure hemoglobin and iron levels Report any side effects or intolerance during treatment
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients of reproductive age (15 to 49 years) with a diagnosis of iron-deficiency anemia secondary to dysfunctional uterine bleeding.
* Patients with iron-deficiency anemia who are treatment-naïve or whose last administration of iron therapy, either oral or parenteral, occurred at least three months prior to enrollment and who continue to have anemia.
* Patients with a functional oral route.
* Signed informed consent.
Exclusion Criteria:
* Patients with abnormal uterine bleeding secondary to cancer
* Severe intolerance to iron supplementation
* Patients with gastritis or chronic use of proton pump inhibitors
* Concomitant treatment with dietary supplements rich in calcium, magnesium, or zinc
* Patients with endocrine disorders (hypothyroidism, hyperthyroidism)
* Uncontrolled type 2 diabetes mellitus
* Associated gastrointestinal bleeding
* Patients with esophageal disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to 3 months in hemoglobin level (g/dL)