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

Thalassemia Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951818
• Other study ID #: 201903041RINB
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2021
• Source: National Taiwan University Hospital
• Contact: Shyang-Rong Shih, MD, PhD
• Phone: +886-972653337
• Email: srshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• beta-Thalassemia
• Thalassemia
• Thalassemia Major

Locations

Country	Name	City	State
Taiwan	Shyang-Rong Shih	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal bone mineral density rate	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.	10 years
Secondary	abnormal thyroid function rate	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.	10 years
Secondary	abnormal pituitary function rate	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)	10 years