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Beta Thalassemia MajorNCT07486531

Iron Accumulation in Erythrocytes in Patients

An observational study of Beta Thalassemia Major, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Beta Thalassemia Major
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Oct 2024to 28 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Ankara Bilkent City Hospital

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Non-Hemoglobin-Bound Iron Accumulation in Hemolysates of Thalassemia Patients

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.

Keywords
Beta thalassemia, Colorimetry, Erythrocyte, Iron, Iron Overload
Medical subject headings
beta-Thalassemia, Iron Overload

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07486531
Study groupRoleWhat they receive
β-thalassemia majorNot described
healthy controlsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intraerythrocyte non-heme iron level

    Measured: One month after ethics committee approval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start20 Oct 2024
  3. Primary completion28 Dec 2024
  4. Study completion28 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486531
Sponsor's protocol ID
TABED 1-24-642
Status last verified
Mar 2026
First submitted
14 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study involves limited participant-level data and no plan exists for external data sharing

Questions about this trial

What is this clinical trial studying?

An observational study of Beta Thalassemia Major, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intraerythrocyte non-heme iron level (time frame: One month after ethics committee approval). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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