Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB

Effect of Serum Vitamin D Level and Vitamin D Receptor on the Efficacy of Pegylated Interferon in Patients With Chronic Hepatitis B With Low Level HBsAg Treated by Nucleos(t)Ide Analogues

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05753280

Enrollment

Registered

2023-03-03

Start date

2018-12-01

Completion date

2022-06-30

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b

Keywords

hepatitis B, Vitamin D, Interferon

Brief summary

In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells, dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies have been carried out at home and abroad. In this study, We will recruit CHB patients with low HBsAg levels. They all will receive pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a control group. A final assessment will be made to determine whether vitamin D levels would affect the clearance rate of HBsAg.

Interventions

DRUGVitamin D

Patients take 800 mg vitamin D capsules daily during the whole treatment period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1.According with the diagnosis of chronic hepatitis B in the guideline of China in 2015 2.18-60 years old 3.More than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA\<100 IU/ml 4.No contraindications of interferon

Exclusion criteria

1. Allergy to interferon 2. Alanine transaminase \>10 times of upper limit of normal(ULN) or total bilirubin \>2 times of ULN 3. existing or previous decompensated liver cirrhosis 4. White blood cells or Platelet below the lower limit of normal 5. existing severe organ injury 6. combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism 7. confirmed or suspected malignant tumors 8. before or after transplantation 9. using immunosuppressor 10. pregnant or having a planned parenthood in 2 years 11. alcohol or drug addicted 12. infected by HIV 13. any conditions that is unsuitable to interferon therapy according to the doctors' judgement

Design outcomes

Primary

Measure	Time frame	Description
hepatitis B surface antigen	up to 48 weeks	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.

Secondary

Measure	Time frame	Description
hepatitis B surface antibody	every 12 weeks for up to 48 weeks	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026