The Relationship Between Vitamin D and Hepatitis B Virus Replication

February 1, 2020 updated by: Chia-Chi Wang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei city, Taiwan, 23142
        • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Other known causes of hepatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D group
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Dietary supplement: Vitamin D
No Intervention: Control group
Patients without receiving vitamin D supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Dynamic Change of HBV DNA
Time Frame: baseline, after 2-month vitamin D supplement
the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement
baseline, after 2-month vitamin D supplement
The Change of Serum qHBsAg (IU/mL)
Time Frame: baseline, after 2-month vitamin D supplement
The serum qHBsAg levels were measured before and after 2-month vitamin D supplement
baseline, after 2-month vitamin D supplement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Principal Investigator: Chia-Chi CC Wang, Master, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 25, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 1, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZ-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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