Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)

Summary

This study investigates the risk of anemia development in women aged 18-55 years with non-anemic iron deficiency and evaluates the clinical effects of oral iron therapy. The study consists of a two-month nutritional intervention phase followed by a one-month oral iron treatment phase. Participants first receive dietary counseling aimed at increasing iron intake and absorption. After two months, changes in hematologic parameters and symptoms are evaluated. Women with persistent iron deficiency then receive daily oral ferrous sulfate (80 mg elemental iron) for one month. The study aims to identify early predictors of anemia progression and to assess the impact of dietary modification and oral iron therapy on symptoms and laboratory findings.

Timeline

Start

2025-09-01

Primary completion

2026-01-01

Completion

2026-02-28

Publications

• Background Ortancil O, Sanli A, Eryuksel R, Basaran A, Ankarali H. Association between serum ferritin level and fibromyalgia syndrome. Eur J Clin Nutr. 2010 Mar;64(3):308-12. doi: 10.1038/ejcn.2009.149. Epub 2010 Jan 20.
• Background Skolmowska D, Glabska D, Kolota A, Guzek D. Effectiveness of Dietary Interventions to Treat Iron-Deficiency Anemia in Women: A Systematic Review of Randomized Controlled Trials. Nutrients. 2022 Jun 30;14(13):2724. doi: 10.3390/nu14132724.
• Results Silva Neto LGR, Santos Neto JED, Bueno NB, de Oliveira SL, Ataide TDR. Effects of iron supplementation versus dietary iron on the nutritional iron status: Systematic review with meta-analysis of randomized controlled trials. Crit Rev Food Sci Nutr. 2019;59(16):2553-2561. doi: 10.1080/10408398.2018.1459469. Epub 2018 Apr 30.
• Results Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
• Results Stefan MW, Gundermann DM, Sharp MH, Jennings BA, Gheith RH, Lowery RP, LowDog T, Ghatak SB, Barbosa J, Wilson JM. Assessment of the Efficacy of a Low-Dose Iron Supplement in Restoring Iron Levels to Normal Range among Healthy Premenopausal Women with Iron Deficiency without Anemia. Nutrients. 2023 Jun 3;15(11):2620. doi: 10.3390/nu15112620.
• Results Nemeth E, Ganz T. Hepcidin and Iron in Health and Disease. Annu Rev Med. 2023 Jan 27;74:261-277. doi: 10.1146/annurev-med-043021-032816. Epub 2022 Jul 29.
• Results Zhu XY, Wu TT, Wang HM, Li X, Ni LY, Chen TJ, Qiu MY, Shen J, Liu T, Ondo WG, Wu YC. Correlates of Nonanemic Iron Deficiency in Restless Legs Syndrome. Front Neurol. 2020 Apr 30;11:298. doi: 10.3389/fneur.2020.00298. eCollection 2020.
• Results Sawada T, Konomi A, Yokoi K. Iron deficiency without anemia is associated with anger and fatigue in young Japanese women. Biol Trace Elem Res. 2014 Jun;159(1-3):22-31. doi: 10.1007/s12011-014-9963-1. Epub 2014 Apr 23.
• Results da Silva Lopes K, Yamaji N, Rahman MO, Suto M, Takemoto Y, Garcia-Casal MN, Ota E. Nutrition-specific interventions for preventing and controlling anaemia throughout the life cycle: an overview of systematic reviews. Cochrane Database Syst Rev. 2021 Sep 26;9(9):CD013092. doi: 10.1002/14651858.CD013092.pub2.
• Results Miles LF, Litton E, Imberger G, Story D. Intravenous iron therapy for non-anaemic, iron-deficient adults. Cochrane Database Syst Rev. 2019 Dec 20;12(12):CD013084. doi: 10.1002/14651858.CD013084.pub2.
• Results Houston BL, Hurrie D, Graham J, Perija B, Rimmer E, Rabbani R, Bernstein CN, Turgeon AF, Fergusson DA, Houston DS, Abou-Setta AM, Zarychanski R. Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 5;8(4):e019240. doi: 10.1136/bmjopen-2017-019240.
• Results Fletcher A, Forbes A, Svenson N, Wayne Thomas D; A British Society for Haematology Good Practice Paper. Guideline for the laboratory diagnosis of iron deficiency in adults (excluding pregnancy) and children. Br J Haematol. 2022 Feb;196(3):523-529. doi: 10.1111/bjh.17900. Epub 2021 Oct 24. No abstract available.
• Results Clenin GE. The treatment of iron deficiency without anaemia (in otherwise healthy persons). Swiss Med Wkly. 2017 Jun 14;147:w14434. doi: 10.4414/smw.2017.14434. eCollection 2017.
• Results WHO guideline on use of ferritin concentrations to assess iron status in individuals and populations [Internet]. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK569880/
• Results Balendran S, Forsyth C. Non-anaemic iron deficiency. Aust Prescr. 2021 Dec;44(6):193-196. doi: 10.18773/austprescr.2021.052. Epub 2021 Dec 1.
• Results Guideline on haemoglobin cutoffs to define anaemia in individuals and populations [Internet]. Geneva: World Health Organization; 2024. Available from http://www.ncbi.nlm.nih.gov/books/NBK602198/
• Results Soppi ET. Iron deficiency without anemia - a clinical challenge. Clin Case Rep. 2018 Apr 17;6(6):1082-1086. doi: 10.1002/ccr3.1529. eCollection 2018 Jun.

Drugs

Indications