The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate

Si 1045/2020

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 fumarate (TDF) is one of nucleotide analogue that is recommended to treated patients with Hepatitis B viral infection. However, long-term TDF therapy may have side effects especially nephrotoxicity and bone toxicity. Previous studies in human immunodeficiency virus (HIV) infected patients who treated with TDF containing regimen antiretroviral therapy, in vitamin D supplement group had a statistic significance of low parathyroid hormone level and better in bone mineral density regardless of initial vitamin D level. Therefore, the main objective of this study is to evaluate the vitamin D and calcium supplement to patients with hepatitis B who have taken TDF, in parathyroid hormone level, bone mineral density, renal function and renal phosphate loss compared to patients who have no vitamin D and calcium supplement.

2022-05-01

2023-08-31

2023-11-30

Completed

Early phase I

64

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

2024-02-09