Vitamin D and Hepatitis B VirusNCT03068767
The Relationship Between Vitamin D and Hepatitis B Virus Replication
A study testing Vitamin D in people with Vitamin D and Hepatitis B Virus, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vitamin D and Hepatitis B Virus
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20 y/o, HBV carrier
- serum vitamin D < 30ng/ml
Who cannot join
- Other known causes of hepatitis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, 23142
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D and Hepatitis B Virus
- Being tested
- Vitamin D
- Keywords
- HBV DNA, qHBsAg
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Patients receiving vitamin D supplement (2000 IU/day) for 2 months Receives: Dietary Supplement: Vitamin D |
| Control group | No intervention | Patients without receiving vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, after 2-month vitamin D supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startSep 2016
- Primary completion1 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D and Hepatitis B VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: vitamin D supplement Group 2: controls
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Chi Wang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Chia-Chi CC Wang, Master, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068767
- Sponsor's protocol ID
- TZ-105
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2017
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- ClinicalTrials.gov ID
- NCT03068767
- Acronym / sponsor ID
- TZ-105
- Conditions
- Vitamin D and Hepatitis B Virus
- Keywords
- HBV DNA, qHBsAg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: vitamin D supplement Group 2: controls
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Dietary Supplement: Vitamin DPatients receiving vitamin D supplement (2000 IU/day) for 2 months |
| Control group | No intervention | –Patients without receiving vitamin D supplement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >20 y/o, HBV carrier
- serum vitamin D < 30ng/ml
Key exclusion criteria (1 listed)
- Other known causes of hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D | Dietary supplement | Vitamin D group |
Primary outcome
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Chi CC Wang, Master principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D and Hepatitis B Virus, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dynamic Change of HBV DNA (time frame: baseline, after 2-month vitamin D supplement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.