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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 : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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

Study Design
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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, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Outcome Measures
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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)


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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


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

Locations
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Taiwan
Shyang-Rong Shih Recruiting
Taipei, Taiwan, 100
Contact: Shyang-Rong Shih    886-23123456    srshih@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Shyang-Rong Shih, MD, PhD National Taiwan University Hospital
More Information
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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: May 17, 2019
Last Verified: May 2019

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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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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn