Randomized controlled trial on the treatment of Hypoferritinemia without Anemia: Comparing oral and intravenous iron supplementation among reproductive age women in Pakistan

Background & Objectives: Hypoferritinemia without anemia (HWA) is an under-recognized public health concern. Early identification and targeted treatment of HWA can prevent unnecessary medication use and potential drug abuse. This study aims to establish clearer guidelines for recognizing and managing HWA, improving patient's outcome. The study objectives will be to compare the treatment efficacy of oral and IV iron on patients with HWA and to check the severity of clinical indicators of HWA post treatment among reproductive age women. Methods: We will choose a multicenter, multi-arm randomized controlled trial with a parallel assignment interventional model. About three hundred participants (n=300) aged 18-45 with hypoferritinemia without anemia and no comorbidities will be recruited. Participants will be randomized into three groups of one hundred each: Group-A will receive oral iron supplements (Iron III Hydroxide Polymaltose Complex, 100 mg elemental iron) one tablet per day for three months; Group-B will receive intravenous iron (Ferric carboxymaltose, one dose per month for three months); Group-C will receive no treatment. All groups will be followed for four months. Conclusion: The primary outcome will be the change in serum ferritin levels among groups at four months post- intervention. Secondary outcomes will include changes in clinical symptoms post-intervention. Data will be analyzed by using independent t-tests for between-group ferritin levels, paired t-tests for within-group comparisons, Wilcoxon Rank and Friedman tests for clinical symptoms, and ANOVA for comparisons across multiple groups.