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NCT05313477 Clinical Trial

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

Vitamin D Clinical Trial

— TDF  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05313477
Other study ID # Si 1045/2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2022
Est. completion date November 30, 2023

Study information
Verified date February 2024
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ergocalciferol Capsules
Depend on initial 25(OH) vitamin D level If <10ng/mL, 60000U of Ergocalciferol capsules per week If 10-19.9ng/mL, 40000U of Ergocalciferol capsules per week If >20 ng/mL, 20000U of Ergocalciferol capsule per week
• Calcium carbonate
1000mg of Calcium carbonate daily

Locations
Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (32)

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Outcome
Type Measure Description Time frame Safety issue
Primary Change in serum parathyroid hormone Change from the baseline in serum parathyroid hormone as assessed by Electrochemiluminescent immunoassay (ECLIA) 48weeks
Secondary Change in bone mineral density Change from the baseline in bone mineral density as assessed by Dual-energy X-ray absorptiometry (DXA) 48weeks
Secondary Renal function changes Change from the baseline in renal function (eGFR) based on creatinine as assessed by Enzymatic method 48weeks
Secondary Change in renal phosphate loss Change from the baseline in the tubular reabsorption of phosphate (TRP) as renal phosphate loss depended on serum creatinine, urine creatine (assessed by enzymatic method) and serum phosphate, urine phosphate (assessed by modification of the classical phosphomolybdate method by Fiske and Subbarow) 48weeks
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