Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Multicenter, Randomized, Open-Label, Non-Inferiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare the effectiveness and tolerability of two different oral iron regimens in adults with iron deficiency anemia (IDA). The main questions it aims to answer are: Is alternate-day oral iron supplementation as effective as once-daily dosing in improving hemoglobin levels? What are the side effects associated with each dosing regimen? Researchers will compare once-daily vs. alternate-day oral ferrous fumarate to evaluate whether alternate-day dosing is non-inferior in terms of hematologic response, with fewer adverse effects. Participants will: Be randomly assigned to take ferrous fumarate 200 mg once daily or 400 mg on alternate days for 8 weeks Undergo blood tests and clinical assessments at baseline, Week 4, and Week 8 Report any side effects and bring remaining pills to evaluate medication adherence This is a multicenter, randomized, open-label, non-inferiority trial conducted in adults aged 20 years or older with IDA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Male or female patients aged ≥20 years diagnosed with iron deficiency anemia, defined as: hemoglobin (Hb) \<13 g/dL in males or \<12 g/dL in females, and ferritin \<50 ng/mL or transferrin saturation (TSAT) \<20%.

• No iron supplementation within the past 3 months.

Locations
Other Locations
Thailand
Phramongkutklao Hospital
RECRUITING
Bangkok
Contact Information
Primary
Tanapun Thamgrang, Doctor of Medicine
tanapun.tham@pcm.ac.th
66859930142
Backup
Aticha Kraiput, Doctor of Medicine
aticha.kr18@gmail.com
66862849871
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 114
Treatments
Active_comparator: Once-Daily Dosing Group
Participants will receive ferrous fumarate 200 mg, taken orally once daily for 8 weeks. This arm represents the standard dosing regimen for treating iron deficiency anemia (IDA). Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.
Experimental: Alternate-Day Dosing Group
Participants will receive ferrous fumarate 400 mg (two 200 mg tablets), taken orally on alternate days for 8 weeks. This dosing strategy is being evaluated for improved iron absorption and fewer gastrointestinal side effects compared to daily dosing. Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.
Related Therapeutic Areas
Sponsors
Leads: Phramongkutklao College of Medicine and Hospital

This content was sourced from clinicaltrials.gov

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