Vitamin D and Hepatitis B Virus
Conditions
Keywords
HBV DNA, qHBsAg
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Group 1: vitamin D supplement Group 2: controls
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>20 y/o, HBV carrier * serum vitamin D \< 30ng/ml
Exclusion criteria
* Other known causes of hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Dynamic Change of HBV DNA | 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) | baseline, after 2-month vitamin D supplement | The serum qHBsAg levels were measured before and after 2-month vitamin D supplement |
Countries
Taiwan
Participant flow
Recruitment details
Chronic HBV patients receiving regular 6-month surveillance in the outpatient clinic of Taipei Tzu Chi Hospital were invited to join the study from August 2017 to September 2018.
Pre-assignment details
All had positive hepatitis B surface antigen (HBsAg) for more than 6 months. Those with positive anti-hepatitis C virus (HCV) antibody, other known causes of chronic hepatitis or receiving antiviral treatment currently were excluded. Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Group Patients receiving vitamin D supplement (2000 IU/day) for 2 months
Vitamin D | 75 |
| Control Group Patients without receiving vitamin D supplement | 74 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 3 |
| Overall Study | Protocol Violation | 3 | 0 |
Baseline characteristics
| Characteristic | Vitamin D Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 68 Participants | 133 Participants |
| Age, Continuous | 51.85 years STANDARD_DEVIATION 10.88 | 51.28 years STANDARD_DEVIATION 8.86 | 51.61 years STANDARD_DEVIATION 9.86 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 83 Participants |
| Sex: Female, Male Male | 32 Participants | 34 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 3 / 75 | 6 / 74 |
| serious Total, serious adverse events | 0 / 75 | 0 / 74 |
Outcome results
Primary
The Change of Serum qHBsAg (IU/mL)
The serum qHBsAg levels were measured before and after 2-month vitamin D supplement
Time frame: baseline, after 2-month vitamin D supplement
Population: Levels of qHBsAg before and after 2 months of vitamin D treatment or follow-up were compared between these two groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Group | The Change of Serum qHBsAg (IU/mL) | 2.19 IU/mL | Standard Deviation 1.03 |
| Control Group | The Change of Serum qHBsAg (IU/mL) | 2.4 IU/mL | Standard Deviation 1.11 |
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
Time frame: baseline, after 2-month vitamin D supplement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Group | The Dynamic Change of HBV DNA | 3.15 IU/mL | Standard Deviation 1.14 |
| Control Group | The Dynamic Change of HBV DNA | 3.14 IU/mL | Standard Deviation 1.36 |