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

NCT07556731 | Not Yet Recruiting Phase 3

• 1 other identifier: HGMIronDeficiency
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Iron-deficiency Anemia (IDA); Hemoglobin; Iron Deficiencies; Adverse Effect

Keywords

Iron-deficiency anemia treatment comparision; Oral iron dosing; Liposomal iron; Iron replacement therapy; ferritin

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and month 3

Secondary Outcomes (10)

• Proportion of participants with any adverse event (%)

  Up to 3 months

• Proportion of participants with specific adverse events (%)

  Up to 3 months

• Proportion of participants with intolerance to iron supplementation (%)

  Up to 3 months

• Proportion of participants who discontinue treatment (%)

  Up to 3 months

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

  Baseline and 3 months.

Study Arms (3)

Oral ferrous fumarate administered every 24 hours

ACTIVE COMPARATOR

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.

Drug: Ferrous fumarate administered orally every 48 hours.; Drug: Liposomal iron formulation.

Ferrous fumarate administered orally every 48 hours.

ACTIVE COMPARATOR

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 48 hours.

Drug: Oral ferrous fumarate administered every 24 hours; Drug: Liposomal iron formulation.

Liposomal iron formulation.

ACTIVE COMPARATOR

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.

Drug: Oral ferrous fumarate administered every 24 hours; Drug: Ferrous fumarate administered orally every 48 hours.

Interventions

Oral ferrous fumarate administered every 24 hours DRUG

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.

Also known as: A arm

Ferrous fumarate administered orally every 48 hours.; Liposomal iron formulation.

Ferrous fumarate administered orally every 48 hours. DRUG

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 48 hours.

Also known as: B arm

Liposomal iron formulation.; Oral ferrous fumarate administered every 24 hours

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.

Also known as: C arm

Ferrous fumarate administered orally every 48 hours.; Oral ferrous fumarate administered every 24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Hospital General de México "Eduardo Liceaga"

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

four-arm poly(ethylene oxide)-b-poly(2-(diethylamino)ethyl methacrylate)

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Christian Omar R. Peñafiel. PhD, MD, PhD

CONTACT

52+5523351588; leukemiachop33@gmail.com

Ernesto V Carpintero, MD

CONTACT

52+7771358561; nerev16@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Haematologist, Head of Department at Hospital General de Mexico,,Editor in Chief "Revista de Hematología de México"

Model Details: This study uses a parallel group interventional design. Eligible participants are randomly assigned to one of three treatment arms and receive only the intervention assigned to their group throughout the entire study period. There is no crossover between treatment arms. Each participant is followed prospectively for three months to assess treatment response and tolerability.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

ME (1)