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

NCT ID: NCT05753280

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-06-30

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.

Conditions

Chronic Hepatitis b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

pegylated interferon 180ug/week and oral vitamin D3 800IU/day for no longer than 48 weeks

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

control group

pegylated interferon 180ug/week for no longer than 48 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhiliang Gao

Academic leader of the infectious diseases department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiliang Gao, Doctor

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

G58

Identifier Type: -

Identifier Source: org_study_id