Clinical Trials Logo

Clinical Trial 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 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.


Clinical Trial 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 cause of hepatocellular carcinoma about 60% in East-Asia and Africa and about 20% in Western countries. About 350-400 million people are infected worldwide. Infection with hepatitis B virus is also an important factor of death in 1million patients per year. 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. Nowadays, the recommendation of nucleot(s)ide prefers Tenofovir disoproxil fumarate (TDF), Tenofovir Alafenamide (TAF) and Entecavir (ETV) than Lamivudine, Adefovir and Telbivudine due to high potency and low resistance rate Tenofovir disoproxil fumarate (TDF) is one of nucleotide analogue that inhibits reverse transcriptase in HBV replication process. However, long-term TDF therapy may have side effects especially nephrotoxicity. The proposed mechanisms of nephrotoxicity of TDF are cumulative of TDF at proximal tubule of kidney leads to mitochondrial toxicity, downregulation of sodium-phosphorus cotransporter, sodium/ hydrogen exchanger 3 and aquaporin 2, decreased endothelial nitric oxide-synthase (eNOS) and renal vasoconstriction results in tubulopathy in renal proximal tubule, increase of phosphate loss in urine and increase od serum creatinine. Moreover, TDF also affects to decrease bone mineral density (BMD) that related with renal phosphate loss, loss of osteoblast function, high parathyroid hormone level regardless of vitamin D level and high fibroblast growth factor 23 (FGF23) leads to worsen in bone mineralization Vitamin D has a protective effect and indicate for osteoporosis treatment. The chronic hepatitis B infected patients with vitamin D deficiency may have a poor prognosis in hepatic fibrosis and high HBV DNA level. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05313477
Study type Interventional
Source Mahidol University
Contact
Status Completed
Phase Phase 4
Start date May 1, 2022
Completion date November 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05186194 - The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures. N/A
Recruiting NCT06101147 - Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome Phase 2
Completed NCT02904421 - 6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
Completed NCT02092701 - Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period N/A
Completed NCT05748249 - Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence Phase 1
Recruiting NCT04844957 - Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS Early Phase 1
Completed NCT01170572 - Longitudinal Study of Patients Following Long Bone Fracture N/A
Not yet recruiting NCT01080950 - Vitamin D Zinc Fever N/A
Active, not recruiting NCT04564625 - Relationships Between Vitamin D and Orthopedic Trauma
Not yet recruiting NCT01992263 - Vitamin D Supplementation and TB N/A
Completed NCT00938600 - Antenatal Vitamin D3 Dose-finding and Safety Study Phase 1
Completed NCT04535791 - Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers Phase 3
Completed NCT04502667 - Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19 Phase 3
Recruiting NCT05448365 - Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid Phase 3
Recruiting NCT03533010 - Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation N/A
Recruiting NCT04404842 - Development of a Screening Tool for the Risk of Vitamin D Deficiency
Recruiting NCT05208827 - Vitamin D Supplementation for the Prevention of GDM Early Phase 1
Completed NCT05209425 - Pharmacokinetics Evaluation of Vitamin D Formulations N/A
Completed NCT02361827 - The Effect of Vitamin D on in Vitro Fertilization Outcome
Withdrawn NCT03073369 - Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease Phase 4