Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
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ClinicalTrials.gov Identifier: NCT03951818 |
Recruitment Status :
Recruiting
First Posted : May 15, 2019
Last Update Posted : February 18, 2021
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Condition or disease |
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Thalassemia Major |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | April 1, 2024 |
Estimated Study Completion Date : | April 1, 2024 |

- Abnormal bone mineral density rate [ Time Frame: 10 years ]abnormal bone mineral density is defined as T-score < -1 SD in menopause women or men older than 50 years old, or Z score < -2 SD in premenopausal women or men not older than 50 year old.
- abnormal thyroid function rate [ Time Frame: 10 years ]abnormal thyroid function is defined as abnormal free thyroxine or abnormal thyrotropin. Normal range of free thyroxine is 0.6-1.75 ng/dl. normal range of thyrotropin is 0.1-4.5 mU/l.
- abnormal pituitary function rate [ Time Frame: 10 years ]abnormal pituitary function is defined as any of the abnormality in serum adrenocorticotropin (pg/l), IGF-1 (ng/ml). thyrotropin (mU/l), FSH (U/l), LH (U/l)

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Ages Eligible for Study: | 20 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Clinical diagnosis of Thalassemia major
- Patients of 20-85 years old
Exclusion Criteria:
- Patients younger than 20 years old.
- Patients older than 85 years old.
- Patients who are pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951818
Contact: Shyang-Rong Shih, MD, PhD | +886-972653337 | srshih@ntu.edu.tw |
Taiwan | |
Shyang-Rong Shih | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Shyang-Rong Shih 886-23123456 srshih@ntu.edu.tw |
Study Director: | Shyang-Rong Shih, MD, PhD | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT03951818 |
Other Study ID Numbers: |
201903041RINB |
First Posted: | May 15, 2019 Key Record Dates |
Last Update Posted: | February 18, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thalassemia beta-Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic |
Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |