Risk Factors Affecting Growth in Thalassemic Children at AUCH

March 28, 2026 updated by: Aya Saleh Sadek, Assiut University

The Effect of Different Risk Factors on Growth Parameters of Thalassemic Patients in Assiut University Children Hospital

Thalassemia major is a hereditary hemoglobinopathy characterized by ineffective erythropoiesis and severe anemia, necessitating lifelong blood transfusions(1,2). Regular transfusions lead to iron overload, a primary driver of growth retardation in affected children. Iron accumulation in tissues like the pituitary and liver disrupts growth hormone secretion and insulin-like growth factor-1 production.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All children with transfusion-dependent beta-thalassemia major attending the AUCH Hematology Unit will be screened for eligibility.

Description

Inclusion Criteria:

  • Children aged 1 to 18 years diagnosed with β-thalassemia major based on hemoglobin electrophoresis or high-performance liquid chromatography (HPLC).
  • Receiving regular blood transfusions as part of standard management at AUCH.
  • Attending the hematology unit for at least one year prior to enrollment.

Exclusion Criteria:

  • • Children with other types of thalassemia.

    • Presence of congenital diseases, chronic illnesses other than thalassemia (e.g., malignancy, tuberculosis, chronic hepatitis, congenital heart disease, chronic renal failure, epilepsy, diabetes mellitus), or primary endocrinopathies.
    • Patients with other causes of short stature, such as hereditary bone dysplasia or systemic disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth parameters: Z-scores for height-for-age, weight-for-age, BMI-for-age
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUCH-TP-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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