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

RecruitingNAAges 18 Years - 55 YearsFemaleIstanbul University - Cerrahpasa
NCT07263529 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female participants aged 18-55 years (including premenopausal and menopausal women). * Normal hemoglobin level (≥ 12 g/dL). * Serum ferritin \< 15 μg/L (WHO criteria for iron deficiency). * Mentzer index \> 13. * Normal levels of vitamin B12, folic acid, thyroid hormones (TSH and sT4), and C-reactive protein (CRP \< 5 mg/L). * Non-anemic iron deficiency confirmed by laboratory results. * Good general health and cognitive capacity to provide informed consent. * Willingness to participate, comply with study procedures, and provide written informed consent. Exclusion Criteria: * Pregnancy or postpartum period. * Acute or chronic infections. * History or suspicion of malignancy. * Chronic inflammatory or autoimmune diseases. * Chronic fatigue syndrome or depressive disorders. * Chronic kidney disease or renal failure (acute or chronic). * Congestive heart failure, ischemic heart disease, or cerebrovascular disease. * Coagulopathy or clinically significant bleeding tendency. * Hematological disorders (e.g., thalassemia, hemoglobinopathies). * Postoperative patients, transplant recipients, or dialysis patients. * Currently using any form of iron supplementation or treatment. * Any condition that, in the investigator's opinion, may interfere with the participant's safety or the interpretation of study results.
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What it tests

  • Dietary Intervention (2 months)
  • Oral Elemental Iron (Ferrous Sulfate) 80 mg/day
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Where

1 site
Kagıthane No. 5 Family Health Center
Kâğıthane, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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