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The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD Vitamin C | Experimental | High dose vitamin C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose vitamin C | Drug | Vitamin C, 3g per day (tid), with meal, per oral with water 100mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks | Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks | Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level | Baseline and 12 weeks |
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Inclusion Criteria:
Chronic hepatitis C patients
Chronic alcoholic hepatitis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Hwan Yoon, M.D, Ph.D | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-171 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | HD Vitamin C | High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HD Vitamin C | High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks | Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level | Posted | Median | Full Range | IU/L | Baseline and 12 weeks |
|
|
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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 | HD Vitamin C | High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jung-Hwan Yoon | Seoul National University Hospital | +82-2-2072-2228 | yoonjh@snu.ac.kr |
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| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D019698 | Hepatitis C, Chronic |
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etiology | Number | participants |
|
| ALT | Median | Full Range | IU/L |
|
|
| Secondary | The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks | Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level | Posted | Median | Full Range | pg/mL | Baseline and 12 weeks |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |