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

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Conditions studied: Non-Anemic Iron Deficiency

In brief

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.

Key facts

Study ID

NCT07263529

Run by

Istanbul University - Cerrahpasa

People needed

60

Starts

2025-09-01

Expected to finish

2026-02-28

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kagıthane No. 5 Family Health Center — Kâğıthane, Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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