Risk of Anemia Development and Clinical Effects of Oral Iron Therapy in Women (18-55 Years) With Non-Anemic Iron Deficiency

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Kagıthane No. 5 Family Health Center
RECRUITING
Kâğıthane
Contact Information
Primary
Osman Demir, MD
osman.demir@iuc.edu.tr
+90 532 291 4470
Backup
Ayşen Fenercioğlu, Assoc Prof
aysen.fenercioglu@iuc.edu.tr
+90 537 964 5751
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 60
Treatments
Experimental: ARM 1 - Nutritional Intervention with Post-Intervention Subgrouping
All participants (N=60) begin with isolated non-anemic iron deficiency and receive a 2-month standardized nutritional intervention to improve iron intake and absorption. Afterward, participants are stratified into five subgroups (ARM1-0 to ARM1-4) based on hematologic response. Subgroups ARM1-1 to ARM1-4 represent persistent deficiency (ferritin \<15 µg/L with normal CRP) and will receive oral elemental iron.~* ARM1-0: Normalized or maintained iron status (no deficiency) - no iron therapy administered.~* ARM1-1: Persistent isolated iron deficiency - receives oral elemental iron.~* ARM1-2: Minimal hemoglobin decline (\<1 g/dL) with microcytosis/hypochromia - receives oral elemental iron.~* ARM1-3: Hemoglobin decline \>1 g/dL but above anemia threshold, with microcytosis/hypochromia - receives oral elemental iron.~* ARM1-4: Overt iron deficiency anemia - receives oral elemental iron.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University - Cerrahpasa

This content was sourced from clinicaltrials.gov