Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia

Phase 3Not Yet RecruitingNCT07556731

Hospital General de Mexico100 enrolled

Overview

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

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.

Interventions

Oral ferrous fumarate administered every 24 hoursDRUG

Administration of ferrous fumarate (each dose contains elemental iron, usually approximately 60 mg, together with ascorbic acid (vitamin C) in an amount of approximately 30 mg. In addition, it includes folic acid at a dose of approximately 400 mcg and vitamin B12 at approximately 8 mcg. Additional inactive ingredients may include excipients and coating agents to facilitate administration and absorption), administered every 24 hours. Participants are instructed to take one tablet or capsule per day, preferably with food to improve absorption and minimize potential gastrointestinal discomfort. The duration of treatment is three months for the recovery of anemia.

Ferrous fumarate administered orally every 48 hours.DRUG

Liposomal iron formulation.DRUG

Administration of an oral supplement combining liposomal iron (19.20 mg of elemental iron), vitamin C (60 mg), and soluble fiber (350 mg). The formulation includes dehydrated glucose syrup, soluble corn fiber, iron in the form of ferric pyrophosphate, natural strawberry flavor, along with vitamins and coloring agents such as beet red and carminic acid. The combination of liposomal iron, vitamin C, and soluble fiber is designed to enhance iron absorption in the body, facilitating its utilization in hemoglobin synthesis and other essential components. The supplement is administered orally once daily (every 24 hours) for a duration of three months.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline to 3 months in hemoglobin level (g/dL)

Hemoglobin concentration will be measured at baseline and at 3 months after initiation of treatment. A favorable response will be defined as an increase of at least 2 g/dL from baseline.

Time frame: Baseline and month 3

Secondary Outcomes

Proportion of participants with any adverse event (%)

Proportion of participants experiencing at least one adverse event during treatment, graded according to CTCAE.

Time frame: Up to 3 months

Proportion of participants with specific adverse events (%)

Proportion of participants experiencing nausea, vomiting, abdominal pain, diarrhea, and constipation during treatment, graded according to CTCAE.

Time frame: Up to 3 months

Proportion of participants with intolerance to iron supplementation (%)

Proportion of participants who develop intolerance to iron supplementation, stratified by formulation (ferrous fumarate and liposomal iron).

Time frame: Up to 3 months

Proportion of participants who discontinue treatment (%)

Proportion of participants who discontinue iron supplementation, stratified by formulation.

Time frame: Up to 3 months

Change from baseline to 3 months in mean corpuscular volume (fL)

Change in mean corpuscular volume (MCV) from baseline to 3 months after initiation of treatment. MCV will be measured in femtoliters (fL) using standard laboratory methods.

Time frame: Baseline and 3 months.

Change from baseline to 3 months in mean corpuscular hemoglobin (pg)

Change in mean corpuscular hemoglobin (MCH) from baseline to 3 months after initiation of treatment. MCH will be measured in picograms (pg) using standard laboratory methods.