The Relationship Between Vitamin D and Hepatitis B Virus Replication
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedResults Posted
Study results publicly available
February 12, 2020
CompletedFebruary 12, 2020
February 1, 2020
2.3 years
February 22, 2017
April 13, 2019
February 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Vitamin D group
EXPERIMENTALPatients receiving vitamin D supplement (2000 IU/day) for 2 months
Control group
NO INTERVENTIONPatients without receiving vitamin D supplement
Interventions
Eligibility Criteria
You may qualify if:
- \>20 y/o, HBV carrier
- serum vitamin D \< 30ng/ml
You may not qualify if:
- Other known causes of hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, 23142, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief of internal medicine department
- Organization
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Chia-Chi CC Wang, Master
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Gastroenterology
Study Record Dates
First Submitted
February 22, 2017
First Posted
March 3, 2017
Study Start
September 1, 2016
Primary Completion
January 1, 2019
Study Completion
January 15, 2019
Last Updated
February 12, 2020
Results First Posted
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share