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

NCT07556731 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

DRUG

Oral ferrous fumarate administered every 24 hours

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.

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

Liposomal iron formulation.

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.

Sponsors & Collaborators

  • Hospital General de Mexico

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2027-07-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556731 on ClinicalTrials.gov