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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03951818
Collaborator
(none)
100
Enrollment
1
Location
60
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Abnormal bone mineral density rate [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 [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 [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

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shyang-Rong Shih Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Director: Shyang-Rong Shih, MD, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03951818
    Other Study ID Numbers:
    • 201903041RINB
    First Posted:
    May 15, 2019
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thalassemia
    beta-Thalassemia

    Study Results

    No Results Posted as of Feb 18, 2021