Status:
COMPLETED
The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With TDF
Lead Sponsor:
Mahidol University
Conditions:
Parathyroid Hormone
Tenofovir Disoproxil Fumarate
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Nucleot(s)ide is an antiviral drug that can reduce the number of viruses, reduce the risk of HCC, regress hepatic fibrosis and reduce death from Hepatitis B viral infection. Tenofovir disoproxil fumar...
Detailed Description
Hepatitis B virus is a global public health problem. This infection leads to chronic hepatitis, cirrhosis and liver cancer. According to past statistics, infection with hepatitis B virus is a common c...
Eligibility Criteria
Inclusion
- Age between 18 - 75 years old
- Chronic hepatitis B infected patients treated with TDF monotherapy
- eGFR ≥ 60 mL/ min/ 1.73 m2
- HBV viral load \<10 IU/ mL
Exclusion
- HIV infection or hepatitis C co-infection
- Decompensated cirrhosis, including variceal bleeding, ascites, hepatic encephalopathy
- History of Hepatocellular carcinoma
- Active malignancy of cancer in other organs
- Pregnancy or lactation
- Primary hyperparathyroidism
- History of thyroid or parathyroid surgery
- History of radiation at neck area
- Any osteoporosis treatment or history of osteoporosis diagnosis
- Chronic kidney disease
- Current use of Vitamin D
- Adverse event or allergy to TDF
- Chronic hepatitis B patients with TDF resistance
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05313477
Start Date
May 1 2022
End Date
November 30 2023
Last Update
September 5 2024
Active Locations (1)
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1
Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700