Preventing anemia and treating low iron in women 18–55
Official title: Risk of Anemia Development and Clinical Effects of Oral Iron Therapy in Women (18-55 Years) With Non-Anemic Iron Deficiency
Run by Istanbul University - Cerrahpasa · NCT07263529 · Data updated 2026-11-12
We will try dietary counseling for two months and, if iron levels stay low, one month of daily oral iron to see if they prevent anemia or improve symptoms in women 18–55 with low ferritin but normal hemoglobin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Kâğıthane, Istanbul) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | February 28, 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07263529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–55 with ferritin <15 µg/L, hemoglobin ≥12 g/dL, normal B12/folate/thyroid and CRP, and no major chronic illnesses are ideal candidates.
✕Probably not a fit
Women who are already anemic, pregnant/postpartum, have active inflammation, chronic disease, or alternative causes of low hemoglobin are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women aged 18–55 with ferritin <15 µg/L and normal hemoglobin (≥12 g/dL) receive two months of standardized dietary counseling to increase iron intake and absorption, with laboratory tests and symptom checks at baseline and two months. Participants who remain iron-deficient after the nutritional phase are given daily oral ferrous sulfate (80 mg elemental iron) for one month, followed by repeat labs and symptom assessment. The study documents hematologic markers (hemoglobin, ferritin, Mentzer index) and screens for alternate causes (B12, folate, thyroid hormones, CRP) to identify individual predictors of progression to anemia. Conducted as a single-center, prospective protocol at Kâğıthane No. 5 Family Health Center in Istanbul, the approach combines pragmatic dietary modification with short-term supplementation to measure clinical and laboratory responses.
Why it matters
Potential benefit: If successful, this approach could prevent progression to anemia and reduce fatigue and other iron-deficiency symptoms using simple dietary guidance and a short course of oral iron.
How similar studies have gone: Previous studies show oral iron reliably raises ferritin and can improve symptoms in iron deficiency, while dietary counseling alone has variable effects, so combining both is plausible but not extensively proven as a prevention strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Kagıthane No. 5 Family Health Center
Kâğıthane, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Osman Demir, MD — Kağıthane No.5 Family Health Center, Istanbul, Turkey
- Study coordinator: Osman Demir, MD
- Email: osman.demir@iuc.edu.tr
- Phone: +90 532 291 4470
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.