The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01413360
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis; Chronic Hepatitis C; Chronic Alcoholic Hepatitis	Drug: High dose vitamin C	Phase 4

Detailed Description

The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HD Vitamin C High dose vitamin C	Drug: High dose vitamin C; Vitamin C, 3g per day (tid), with meal, per oral with water 100mL; Other Names: Koreaeundan Vitamin C 1000

Outcome Measures

Primary Outcome Measures

1. The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks [Baseline and 12 weeks]

   Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level

Secondary Outcome Measures

1. The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks [Baseline and 12 weeks]

   Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chronic hepatitis C patients

• positive anti-HCV antibody more than 6 months

• serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

• not indicated for antiviral therapy with interferon and ribavirin

1. Chronic alcoholic hepatitis

• significant alcohol drinking history and no other cause of chronic hepatitis

• serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

Exclusion Criteria:

• Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis

• decompensated liver cirrhosis

• platelet < 50,000/uL or white blood cell < 1,500/uL

• need and willing for antiviral therapy

• significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone

• hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks

• pregnancy, lactating woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-171

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Director: Jung-Hwan Yoon, M.D, Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01413360
• Other Study ID Numbers: VitC
• First Posted: Aug 10, 2011
• Last Update Posted: Jul 15, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Hepatitis, Alcoholic; Vitamins; Ascorbic Acid

Study Results

Participant Flow

Arm/Group Title	HD Vitamin C
Arm/Group Description	High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Period Title: Overall Study
STARTED	10
COMPLETED	7
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	HD Vitamin C
Arm/Group Description	High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Overall Participants	10
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Region of Enrollment (participants) [Number]
Korea, Republic of	10 100%
Etiology (participants) [Number]
HCV	7 70%
Alcohol	3 30%
ALT (IU/L) [Median (Full Range) ]
Median (Full Range) [IU/L]	65

Outcome Measures

1. Primary Outcome

Title	The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Description	Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HD Vitamin C
Arm/Group Description	High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Measure Participants	7
ALT baseline	77.5
ALT 12 weeks	105.5

2. Secondary Outcome

Title	The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Description	Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HD Vitamin C
Arm/Group Description	High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Measure Participants	7
IL-22 baseline	3.66
IL-22 after 12 weeks	4.04

Adverse Events

Arm/Group Title	HD Vitamin C
Arm/Group Description	High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
All Cause Mortality
	HD Vitamin C
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	HD Vitamin C
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	HD Vitamin C
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Gastrointestinal disorders
Dyspepsia	1/10 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.