Back to resultsThe Relationship Between Vitamin D and Hepatitis B Virus Replication
Primary Purpose
Vitamin D and Hepatitis B Virus
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional health services research trial for Vitamin D and Hepatitis B Virus focused on measuring HBV DNA, qHBsAg
Eligibility Criteria
Inclusion Criteria:
- >20 y/o, HBV carrier
- serum vitamin D < 30ng/ml
Exclusion Criteria:
- Other known causes of hepatitis
Sites / Locations
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin D group
Control group
Arm Description
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Patients without receiving vitamin D supplement
Outcomes
Primary Outcome Measures
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
The Change of Serum qHBsAg (IU/mL)
The serum qHBsAg levels were measured before and after 2-month vitamin D supplement
Secondary Outcome Measures
Full Information
NCT ID
NCT03068767
First Posted
February 22, 2017
Last Updated
February 1, 2020
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03068767
Brief Title
The Relationship Between Vitamin D and Hepatitis B Virus Replication
Official Title
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D and Hepatitis B Virus
Keywords
HBV DNA, qHBsAg
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: vitamin D supplement Group 2: controls
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D group
Arm Type
Experimental
Arm Description
Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients without receiving vitamin D supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Primary Outcome Measure Information:
Title
The Dynamic Change of HBV DNA
Description
the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement
Time Frame
baseline, after 2-month vitamin D supplement
Title
The Change of Serum qHBsAg (IU/mL)
Description
The serum qHBsAg levels were measured before and after 2-month vitamin D supplement
Time Frame
baseline, after 2-month vitamin D supplement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>20 y/o, HBV carrier
serum vitamin D < 30ng/ml
Exclusion Criteria:
Other known causes of hepatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Chi CC Wang, Master
Organizational Affiliation
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
New Taipei city
ZIP/Postal Code
23142
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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The Relationship Between Vitamin D and Hepatitis B Virus Replication
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