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CompletedNCT07486531Updated Mar 20, 2026

Iron Accumulation in Erythrocytes in Patients

An observational study in Beta Thalassemia Major, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
10 Years to 35 Years
Sex
All
01

Study summary

Thalassemia refers to a group of blood disorders characterized by a decrease or absence of the synthesis of one or more normal globin chains. Depending on their clinical severity and transfusion requirements, they can be divided into transfusion-dependent and non-transfusion-dependent thalassemias. In patients with beta-thalassemia major, Hb A synthesis is very low, and Hb F constitutes more than 80% of total hemoglobin. These patients are often transfusion-dependent to ensure tissue oxygenation and suppress ineffective erythropoiesis. Transfusion-dependent patients also need to start iron chelation therapy after a period to prevent iron accumulation in the body. While procedures such as liver biopsy and cardiac MRI (magnetic resonance imaging) exist to directly determine tissue iron accumulation, these procedures are invasive, time-consuming, costly, and require a suitable environment. Therefore, the decision to start iron chelation therapy and adjust the dosage is often made by monitoring ferritin levels, which indicate tissue iron accumulation. Serum ferritin is the most commonly used technique for indirectly indicating body iron stores.

Iron accumulation in the body due to frequent transfusions affects not only tissues such as the liver, heart, and nervous system, but also erythroid cells. While previous studies have frequently measured plasma iron not bound to transferrin, also known as labile plasma iron, there are also publications analyzing intracellular labile iron by staining with calcein and using flow cytometry. Another study measured free iron within erythrocytes using HPLC (high-pressure liquid chromatography). However, both HPLC and flow cytometry are expensive and difficult techniques requiring technician expertise and are not available in every laboratory. In our study, we aim to modify the colorimetric method used for traditional iron measurement and measure hemoglobin-free iron in hemolysate samples obtained from erythrocytes. In simpler terms, we aim to detect iron accumulation in the erythrocytes of thalassemia patients who receive frequent transfusions. As is known, serum ferritin monitoring is a parameter that influences the decision to start iron chelation therapy and the treatment dose in thalassemia patients. However, serum ferritin monitoring has some serious disadvantages. Serum ferritin is an indirect indicator of iron overload, showing a nonlinear response to high iron overload; the absence of a decrease in serum ferritin during follow-up does not preclude this response. Furthermore, ferritin is a positive acute phase reactant, and serum levels increase in many cases, making it difficult to differentiate whether the increase in thalassemia patients is due to accumulation or infection. In our study, we aim to directly assess changes in iron overload at the cellular level, as opposed to ferritin, by measuring intracellular iron that is not bound to hemoglobin.

02

Conditions studied

  • Beta Thalassemia Major

Keywords

  • Beta thalassemia
  • Colorimetry
  • Erythrocyte
  • Iron
  • Iron Overload
03

In context

beta-Thalassemia

294 studies on the registry are indexed under beta-Thalassemia; 69 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 75 observational studies indexed under beta-Thalassemia.

Browse beta-Thalassemia studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ankara Bilkent City Hospital

Eligibility criteria

Inclusion Criteria:

  • diagnosis of beta thalassemia major

Exclusion Criteria: Samples taken immediately after transfusion

  • insufficient-complete blood count samples
  • patients with thalassemia intermedia
  • patients showing signs of active infection
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • β-thalassemia major
  • healthy controls
06

What researchers measure

Primary outcomes

  1. intraerythrocyte non-heme iron level

    Time frame: One month after ethics committee approval

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — The study involves limited participant-level data and no plan exists for external data sharing

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Dec 2024, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2026
First posted
Mar 20, 2026
StartActual
Oct 20, 2024
Primary completionActual
Dec 28, 2024
CompletionActual
Dec 28, 2024
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07486531
Responsible party
Esra Yıldırım Demirçin (Uzman Doktor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Mar 20, 2026
Start date
Oct 20, 2024
Primary completion
Dec 28, 2024
Completion
Dec 28, 2024
Last update
Mar 20, 2026

Study contacts

Salim NEŞELİOĞLU, MD
study director · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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