Abstract
Recent studies in iron-depleted women have challenged the current approach of treating iron-deficiency anemia (IDA) with oral iron in divided daily doses. Alternate day dosing leads to more fractional absorption of iron. In this randomized controlled trial, we looked at the efficacy and safety of alternate-day (AD) versus twice-daily (BD) oral iron in all severity of IDA. Total of 62 patients were randomized, 31 patients in BD arm received 60 mg elemental iron twice daily while 31 patients in AD arm received 120 mg iron on alternate days. The primary endpoint of 2 g/dl rise in hemoglobin was met in significantly more patients in the BD arm at 3 weeks (32.3% vs. 6.5%, p < 0.0001) and 6 weeks (58% vs. 35.5%, p = 0.001). There was a significant rise in the median hemoglobin at 3 (1.6 vs. 1.1, p = 0.02) and 6 weeks (2.9 vs. 2.0 g/dl, p = 0.03) in the BD arm. However, the median hemoglobin rise in the AD arm at 6 weeks was not significantly different than the BD arm at 3 weeks. Alternate-day dosing for 6 weeks and twice-daily dosing for 3 weeks resulted in the provision of the same total amount of iron. There were more reports of nausea in the BD arm (p = 0.03). In conclusion, the choice of twice-daily or alternate-day oral iron therapy should depend on the severity of anemia, the rapidity of response desired, and patient preference to either regimen due to adverse events. Trial Registration: CTRI reg. no. CTRI/2018/07/015106 http://ctri.nic.in/Clinicaltrials/login.php.
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Funding
This study was funded in part by an intramural grant (IM/2018/99) to DPL and RK from the Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, India. The funder of the study had no role in study design; the collection, analysis, and interpretation of the data; or in the writing of the report. DPL and RK had full access to all the data in the study and the final responsibility to submit the paper for publication.
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DPL, PM, SV, and PB conceived and designed the study. All authors were involved in patient recruitment and clinical care of the patients. PB, RD, and NV analyzed the lab data. DPL, RK, PB, and PM drafted the manuscript. All authors revised the manuscript and approved the final version.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Kaundal, R., Bhatia, P., Jain, A. et al. Randomized controlled trial of twice-daily versus alternate-day oral iron therapy in the treatment of iron-deficiency anemia. Ann Hematol 99, 57–63 (2020). https://doi.org/10.1007/s00277-019-03871-z
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DOI: https://doi.org/10.1007/s00277-019-03871-z