The Relationship Between Vitamin D and Hepatitis B Virus Replication

NCT ID: NCT03068767

Last Updated: 2020-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-01-15

Brief Summary

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149 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication were compared before and after treatment.

Detailed Description

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This is a randomized case-control trial. A total of 149 HBV carriers with inadequate vitamin D (\< 30 ng/mL) level were enrolled. They were randomly divided to two groups: one group receiving vitamin D supplement (1600 IU/day) for 2 months and another group as controls. The serum vitamin D, HBV DNA and qHBsAg levels were measured at baseline and after vitamin D supplement. Whether HBV DNA and qHBsAg have significant change after vitamin D supplement can be determined.

Conditions

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Vitamin D and Hepatitis B Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: vitamin D supplement Group 2: controls
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vitamin D group

Patients receiving vitamin D supplement (2000 IU/day) for 2 months

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Control group

Patients without receiving vitamin D supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* \>20 y/o, HBV carrier
* serum vitamin D \< 30ng/ml

Exclusion Criteria

* Other known causes of hepatitis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Chia-Chi Wang

Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chia-Chi CC Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Locations

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TZ-105

Identifier Type: -

Identifier Source: org_study_id

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