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Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 47% 114 → 60 participants
See other at-risk trials from Phramongkutklao College of Medicine and Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 57 words
  2. Enrollment reduced: 114 → 60 participants
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study title revised
  3. Eligibility criteria expanded, about 51 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07014371
Lead Sponsor Phramongkutklao College of Medicine and Hospital
Conditions
(from sponsor)		 Iron Deficiency Anemia Treatment
Related terms Anemia, Iron-Deficiency
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov