Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital General de Mexico
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Oral ferrous fumarate administered every 24 hours
- Ferrous fumarate administered orally every 48 hours.
- Liposomal iron formulation.
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Hospital General de Mexico
Lead sponsor
Hospital General de México Dr. Eduardo Liceaga
Sponsor institution
Source ClinicalTrials.gov