Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
NCT07263529

Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)

Led by Istanbul University - Cerrahpasa · Updated on 2025-12-04

60

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 vitamin B12, folic acid, thyroid hormones (TSH and sT4), and C-reactive protein (CRP < 5 mg/L) levels
  • Non-anemic iron deficiency confirmed by laboratory results
  • Good general health and ability to provide informed consent
  • Willingness to participate, comply with study procedures, and provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 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 interfering with safety or study result interpretation as judged by investigator

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Trial Site Locations

Total: 1 location

1

Kagıthane No. 5 Family Health Center

Kâğıthane, Istanbul, Turkey (Türkiye), 34413

Actively Recruiting

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Research Team

O

Osman Demir, MD

CONTACT

A

Ayşen Fenercioğlu, Assoc Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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