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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | Patients receiving vitamin D supplement (2000 IU/day) for 2 months |
|
| Control group | No Intervention | Patients without receiving vitamin D supplement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia-Chi CC Wang, Master | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | New Taipei City | 23142 | Taiwan |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Group | Patients receiving vitamin D supplement (2000 IU/day) for 2 months Vitamin D |
| FG001 | Control Group | Patients without receiving vitamin D supplement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D Group | Patients receiving vitamin D supplement (2000 IU/day) for 2 months Vitamin D |
| BG001 | Control Group | Patients without receiving vitamin D supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | IU/mL | baseline, after 2-month vitamin D supplement |
|
|
2 months
Death: 0% Serious adverse event: 0% adverse event: 6%
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Group | Patients receiving vitamin D supplement (2000 IU/day) for 2 months Vitamin D No serious adverse events noted. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tearing | Eye disorders | Systematic Assessment | increased tear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief of internal medicine department | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | +886-2-6628-9779 | 2317 | uld888@yahoo.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2017 | Feb 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2017 | Feb 1, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Group 1: vitamin D supplement Group 2: controls
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded. The eligible subjects were randomized into two groups by using the computer random distribution. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | The Change of Serum qHBsAg (IU/mL) | The serum qHBsAg levels were measured before and after 2-month vitamin D supplement | Levels of qHBsAg before and after 2 months of vitamin D treatment or follow-up were compared between these two groups. | Posted | Mean | Standard Deviation | IU/mL | baseline, after 2-month vitamin D supplement |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 3 |
| 75 |
| EG001 | Control Group | Patients without receiving vitamin D supplement No serious adverse events noted. | 0 | 74 | 0 | 74 | 6 | 74 |
| urine occult blood positive | Renal and urinary disorders | Non-systematic Assessment | Positive urine occult blood in urinalysis |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | feel difficulty in breathing |
|
| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | skin rash over legs |
|
| sneezing | Ear and labyrinth disorders | Non-systematic Assessment | sneezing |
|
| acid reflux | Gastrointestinal disorders | Non-systematic Assessment | sometimes acid reflux |
|
| leg soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | leg soreness |
|
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |