Preventing anemia and treating low iron in women 18–55
Risk of Anemia Development and Clinical Effects of Oral Iron Therapy in Women (18-55 Years) With Non-Anemic Iron Deficiency
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Kâğıthane, Istanbul) |
| Trial ID | NCT07263529 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kâğıthane, Istanbul
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.