NCT05313477CompletedPhase 4
The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With TDF
The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate
Source: ClinicalTrials.gov · Last updated 5 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 7 Mar 2022
- Start date
- 1 May 2022
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- Mahidol University
- Diseases
- Hepatitis B
- NCT number
- NCT05313477
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 64
- From 1 May 2022 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of thyroid or parathyroid surgery
- History of radiation at neck area
- Any osteoporosis treatment or history of osteoporosis diagnosis
- Chronic kidney disease
- Adverse event or allergy to TDF
- Chronic hepatitis B patients with TDF resistance
Other
- Pregnancy or lactation
- Primary hyperparathyroidism
- Current use of Vitamin D
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.