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Trial Outcomes & Findings for The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients (NCT NCT01413360)

NCT ID: NCT01413360

Last Updated: 2016-07-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2016-07-15

Participant Flow

Participant milestones

Participant milestones
Measure
HD Vitamin C
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Overall Study
STARTED
10
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
HD Vitamin C
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Overall Study
Lost to Follow-up
2
Overall Study
Adverse Event
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HD Vitamin C
n=10 Participants
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Age, Continuous
62 years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Region of Enrollment
Korea, Republic of
10 participants
n=5 Participants
Etiology
HCV
7 participants
n=5 Participants
Etiology
Alcohol
3 participants
n=5 Participants
ALT
65 IU/L
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Outcome measures
Measure
HD Vitamin C
n=7 Participants
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
ALT baseline
77.5 IU/L
Interval 41.0 to 142.0
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
ALT 12 weeks
105.5 IU/L
Interval 13.0 to 170.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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

Outcome measures

Outcome measures
Measure
HD Vitamin C
n=7 Participants
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
IL-22 baseline
3.66 pg/mL
Interval 1.32 to 11.84
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
IL-22 after 12 weeks
4.04 pg/mL
Interval 0.32 to 5.2

Adverse Events

HD Vitamin C

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
HD Vitamin C
n=10 participants at risk
High dose vitamin C High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Gastrointestinal disorders
Dyspepsia
10.0%
1/10

Additional Information

Jung-Hwan Yoon

Seoul National University Hospital

Phone: +82-2-2072-2228

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place