The Relationship Between Vitamin D and Hepatitis B Virus Replication

Vitamin D and Hepatitis B Virus Clinical Trial

Official title:

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068767
• Other study ID #: TZ-105
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2020
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 15, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• >20 y/o, HBV carrier

• serum vitamin D < 30ng/ml

Exclusion Criteria:

• Other known causes of hepatitis

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Vitamin D and Hepatitis B Virus

Intervention

Dietary Supplement:
• Vitamin D

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	New Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Dynamic Change of HBV DNA	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
Primary	The Change of Serum qHBsAg (IU/mL)	The serum qHBsAg levels were measured before and after 2-month vitamin D supplement	baseline, after 2-month vitamin D supplement