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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: Vitamin D


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>pegylated interferon 180ug/week and oral vitamin D3 800IU/day for no longer than 48 weeks | Drug: Vitamin D<br>* Patients take 800 mg vitamin D capsules daily during the whole treatment period<br>|
| No Intervention: control group<br>pegylated interferon 180ug/week for no longer than 48 weeks | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B, Vitamin D, Interferon