Trial · NCT03829683

Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

NCT03829683, Phase 2, Completed, Virginia Commonwealth University; results first posted 2023-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis. Trials, record NCT03829683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829683

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis
NCT number: NCT03829683
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Virginia Commonwealth University
Conditions: Alcoholic Hepatitis, Sepsis
Interventions: Vitamin C, Dextrose 5% in water
First posted: 2019-02-04
Last updated: 2023-08-28
Results first posted: 2023-03-21

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Model for End Stage Liver Disease (MELD) Score	Baseline and 96 hours	Change in MELD score from Day 0 to Day 4. MELD score ranges from 6 (least sick) to 40 (most sick) based on blood tests which ranks the degree of sickness from liver disease. The lab tests used to determine the MELD score are creatinine, bilirubin, and international normalized ratio (INR).
Secondary	Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score	Baseline and 96 hours	A number that ranges from 0 (least sick) to 24 (most sick) and ranks the degree of sickness from liver failure and several other organ systems in a critically ill person. The score is determined by evaluating a person's liver function, kidney function, nervous system (brain), coagulation (blood clotting), circulation (blood pressure), and respiratory status (breathing)
Secondary	Change in Aspartate Aminotransferase (AST) Level	Baseline and 96 hours	Standard blood test used to determine the severity and nature of liver problems.
Secondary	Change in Alanine Aminotransferase (ALT) Level	Baseline and 96 hours	Standard blood test used to determine the severity and nature of liver problems.
Secondary	Change in Total Bilirubin	Baseline and 96 hours	Standard blood test used to determine the severity and nature of liver problems.
Secondary	Change in Alkaline Phosphatase	Baseline and 96 hours	Standard blood test used to determine the severity and nature of liver problems.
Secondary	Change in Albumin	Baseline and 96 hours	Standard blood test used to determine the severity and nature of liver problems.
Secondary	Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0	up to 96 hours	Observation about the need to change the dose of study medication and symptoms such as headache, dizziness, dry mouth, nausea, vomiting, flushing, rash, or hypotension (low blood pressure)
Secondary	Changes to Corrected QT Interval (QTc)	Baseline and 96 hours	An electrocardiogram (ECG or test of the electrical activity of the heart) is performed to determine if there are changes to the heart rhythm.
Secondary	Changes to Urine pH	Baseline and 96 hours	Urine samples are collected to determine changes in pH (acidity) that could indicate a risk for kidney stones. The pH scale ranges from 0 to 14, with smaller numbers meaning more acidic and higher numbers meaning more basic. A pH of 7 is considered to be neutral. Normal levels of urine pH range from 4.6 - 8 on the pH scale.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Model for End Stage Liver Disease (MELD) Score	Baseline and 96 hours	Labs were not collected from 4 participants on day 4 so change in MELD score could not be calculated for those participants and they are omitted from the analysis.	score on a scale	MEAN
SECONDARY	Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score	Baseline and 96 hours	Data not recorded for all participants	score on a scale	MEAN
SECONDARY	Change in Aspartate Aminotransferase (AST) Level	Baseline and 96 hours		IU/L	MEAN
SECONDARY	Change in Alanine Aminotransferase (ALT) Level	Baseline and 96 hours		IU/L	MEAN
SECONDARY	Change in Total Bilirubin	Baseline and 96 hours		mg/dL	MEAN
SECONDARY	Change in Alkaline Phosphatase	Baseline and 96 hours		U/L	MEAN
SECONDARY	Change in Albumin	Baseline and 96 hours		g/dL	MEAN
SECONDARY	Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0	up to 96 hours		Adverse Events	NUMBER
SECONDARY	Changes to Corrected QT Interval (QTc)	Baseline and 96 hours		milliseconds	MEAN
SECONDARY	Changes to Urine pH	Baseline and 96 hours		units on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group37

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Model for End Stage Liver Disease (MELD) Score	Vitamin C Infusion (Ascorbic Acid)	All patients	-0.13	Standard Deviation 7.0	score on a scale
Change in Model for End Stage Liver Disease (MELD) Score	Placebo	All patients	-2.9	Standard Deviation 3.3	score on a scale
Change in Model for End Stage Liver Disease (MELD) Score	Vitamin C Infusion (Ascorbic Acid)	Patients alive at 4 weeks	-2.3	Standard Deviation 5.2	score on a scale
Change in Model for End Stage Liver Disease (MELD) Score	Placebo	Patients alive at 4 weeks	-2.4	Standard Deviation 1.3	score on a scale
Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score	Vitamin C Infusion (Ascorbic Acid)	Baseline	14	Standard Deviation NA	score on a scale
Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score	Placebo	Baseline	15.33	Standard Deviation 0.577	score on a scale
Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score	Placebo	Day 4	12.75	Standard Deviation 1.708	score on a scale
Change in Aspartate Aminotransferase (AST) Level	Vitamin C Infusion (Ascorbic Acid)		176.0	Standard Deviation 466.28	IU/L
Change in Aspartate Aminotransferase (AST) Level	Placebo		-16.5	Standard Deviation 53.07	IU/L
Change in Alanine Aminotransferase (ALT) Level	Vitamin C Infusion (Ascorbic Acid)		62.71	Standard Deviation 155.26	IU/L

1 to 10 of 37Source ClinicalTrials.gov

See all 37 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vitamin C Infusion (Ascorbic Acid)	10
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	Vitamin C Infusion (Ascorbic Acid)	5
Overall Study	COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Vitamin C Infusion (Ascorbic Acid)	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypokalemia	Metabolism and nutrition disorders	Vitamin C Infusion (Ascorbic Acid)	1	10	1
other	Hypokalemia	Metabolism and nutrition disorders	Placebo	3	10	3
other	Abdominal pain	Gastrointestinal disorders	Vitamin C Infusion (Ascorbic Acid)	1	10	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	10	0
other	Bladder spasm	Renal and urinary disorders	Vitamin C Infusion (Ascorbic Acid)	0	10	0
other	Bladder spasm	Renal and urinary disorders	Placebo	1	10	1
other	Deep vein thrombosis	Vascular disorders	Vitamin C Infusion (Ascorbic Acid)	1	10	1
other	Deep vein thrombosis	Vascular disorders	Placebo	0	10	0
other	Electrocardiogram QT corrected interval	Investigations	Vitamin C Infusion (Ascorbic Acid)	1	10	1
other	Electrocardiogram QT corrected interval	Investigations	Placebo	0	10	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vitamin C Infusion (Ascorbic Acid)	5	10
Total, all-cause mortality	Placebo	4	10
Total, other adverse events	Vitamin C Infusion (Ascorbic Acid)	7	10
Total, other adverse events	Placebo	5	10
Total, serious adverse events	Vitamin C Infusion (Ascorbic Acid)	2	10
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AA026966	Novel Therapies for Alcoholic Hepatitis with Sepsis and for Relapse Prevention	SANYAL, ARUN J	VIRGINIA COMMONWEALTH UNIVERSITY	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2018 to 2022

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vitamin C Infusion (Ascorbic Acid) vs Placebo: Changes to Level of Medical Care	Trial comparisons
Vitamin C Infusion (Ascorbic Acid) vs Placebo: deaths from any cause	Trial comparisons
Vitamin C Infusion (Ascorbic Acid) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03829683

GET https://conductscience.org/api/trials/v1/NCT03829683/results?page=2

API reference For AI assistants