NCT07263529 Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)
| NCT ID | NCT07263529 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Non-Anemic Iron Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Osman Demir, MD
PRINCIPAL INVESTIGATOR
Kağıthane No.5 Family Health Center, Istanbul, Turkey
Frequently Asked Questions
Who can join the NCT07263529 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Non-Anemic Iron Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07263529 currently recruiting?
Yes, NCT07263529 is actively recruiting participants. Contact the research team at osman.demir@iuc.edu.tr for enrollment information.
Where is the NCT07263529 trial being conducted?
This trial is being conducted at Kâğıthane, Turkey (Türkiye).
Who is sponsoring the NCT07263529 clinical trial?
NCT07263529 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Osman Demir, MD at Kağıthane No.5 Family Health Center, Istanbul, Turkey. The trial plans to enroll 60 participants.