Dietary Intervention (2 months)Oral Elemental Iron (Ferrous Sulfate) 80 mg/day
Dietary Intervention (2 months): A two-month nutritional counseling program for all participants (N = 60) with isolated non-anemic iron deficiency. The program emphasized the inclusion of iron-rich foods (both heme and non-heme sources), the use of enhancers of iron absorption (such as vitamin C), and practical strategies to reduce absorption inhibitors (e.g., limiting tea and coffee consumption around meals, reviewing antacid use). Participants received biweekly phone follow-ups to monitor adherence and assess symptoms.
Oral Elemental Iron (Ferrous Sulfate) 80 mg/day: One-month oral therapy with 80 mg elemental iron (ferrous sulfate) daily for participants with persistent iron deficiency after the nutritional phase (ferritin \< 15 µg/L). Biweekly phone follow-up for adherence and symptom checks. Adherence and side effects monitored at clinic visit or by phone.
Study 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
Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from Baseline in Patient-Reported Iron Deficiency Symptom Scores After 2-Month Nutritional Intervention and 1-Month Oral Iron Therapy — Baseline, Week 8 (post-nutritional intervention), Week 12 (post-oral iron therapy) Change in patient-reported symptoms including fatigue, weakness, dizziness, and cognitive function etc. measured at baseline, after 2-month nutritional intervention, and after 1-month oral iron therapy.
Trial sites (1)
Facility
City
Region
Status
Kagıthane No. 5 Family Health Center
Kâğıthane
Istanbul
Recruiting
More Istanbul University - Cerrahpasa trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
