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Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03951818
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.

Condition or disease
Thalassemia Major

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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)

Information from the National Library of Medicine

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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
Study Population
20-85 years old thalassemia major patients treated in the OPD of NTUH

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

Information from the National Library of Medicine

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

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Contact: Shyang-Rong Shih, MD, PhD +886-972653337 srshih@ntu.edu.tw

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Shyang-Rong Shih Recruiting
Taipei, Taiwan, 100
Contact: Shyang-Rong Shih    886-23123456    srshih@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
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Study Director: Shyang-Rong Shih, MD, PhD National Taiwan University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn