Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia
100 patients around the world
Available in Mexico
Iron-deficiency anemia is the most common type of anemia worldwide and disproportionately
affects adult women, particularly those with chronic or abnormal uterine bleeding. This
condition can lead to fatigue, reduced physical and cognitive performance, and impaired
quality of life. Oral iron supplementation is the standard first-line treatment; however,
conventional ferrous salt formulations are frequently associated with gastrointestinal
side effects that limit adherence and reduce treatment effectiveness in real-world
settings.
Ferrous salts, such as ferrous fumarate, are effective in replenishing iron stores but
often cause nausea, abdominal discomfort, constipation, or diarrhea. These adverse
effects may lead to poor compliance or early discontinuation. Recent evidence suggests
that alternate-day dosing of ferrous salts may improve tolerability by reducing
intestinal iron overload and hepcidin-mediated absorption blockade, but comparative data
remain limited.
Liposomal iron is an alternative oral formulation in which iron is encapsulated within
phospholipid vesicles. This technology allows iron to be absorbed through different
intestinal pathways, reducing direct contact with the gastrointestinal mucosa and
potentially minimizing adverse effects. Liposomal iron may therefore offer similar or
improved efficacy with better tolerability, but clinical evidence comparing it directly
with standard ferrous salts in adult women with iron-deficiency anemia is still
insufficient.
This study is designed as a prospective, randomized, controlled clinical trial to compare
the effectiveness and tolerability of three oral iron supplementation strategies in adult
women with iron-deficiency anemia secondary to abnormal uterine bleeding. Eligible
participants will be randomly assigned to one of three treatment groups: daily ferrous
salt, ferrous salt administered every other day, or daily liposomal iron. All treatments
will be administered orally for a total duration of three months.
The primary outcome of the study is the change in hemoglobin concentration from baseline
to the end of treatment. Secondary outcomes include changes in iron metabolism parameters
(such as ferritin and serum iron), red blood cell indices, frequency of gastrointestinal
adverse events, and rates of treatment intolerance or discontinuation.
Participants will undergo baseline clinical evaluation and laboratory testing before
starting treatment. Follow-up assessments will be conducted to monitor hematologic
response, adherence, and safety. Adverse events will be documented throughout the study
period. The study aims to identify whether liposomal iron or modified dosing of ferrous
salts can provide a more tolerable and effective treatment option for women with
iron-deficiency anemia.
By comparing these commonly used oral iron strategies, this study seeks to generate
evidence that may inform clinical decision-making and optimize anemia management, with
the goal of improving patient adherence, treatment outcomes, and overall quality of care.
Hospital General de Mexico
1Research sites
100Patients around the world
This study is for people with
Anemia
Iron deficiency anemia
Requirements for the patient
From 18 Years
Female
Medical requirements
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.
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.
Sites
Hospital General de Mexico Dr. Eduardo Liceaga - Ciudad de México
Dr. Balmis 148, Col. Doctores, Del. Cuauhtémoc, Ciudad de México