Trial · NCT00573313
Effects of SAMe in Patients With Alcoholic Liver Disease
NCT00573313, Phase 3, Completed, University of California, Davis; results first posted 2013-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of SAMe in Patients With Alcoholic Liver Disease. Trials, record NCT00573313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of SAMe in Patients With Alcoholic Liver Disease
- NCT number
- NCT00573313
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- University of California, Davis
- Conditions
- Liver Disease, Alcoholic
- Interventions
- S-adenosylmethionine, Placebo
- First posted
- 2007-12-14
- Last updated
- 2017-05-30
- Results first posted
- 2013-06-10
- Limitations and caveats
Relatively small numbers of subjects analyzed with 13 each completers in the treatment and placebo groups. Within each group, violation of protocal by resumption of alcohol intake accounted for dropouts.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Serum AST Levels | Week 0 to week 24 | Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups. |
| Secondary | Changes in Serum SAM | September 2005- June 2009 | We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Serum AST Levels | Week 0 to week 24 | Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease. | Units per liter (U/L) | MEDIAN |
| SECONDARY | Changes in Serum SAM | September 2005- June 2009 | Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables. | nmol/liter | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Serum AST Levels | S-adenosylmethionine (SAMe) | -13.5 | Full Range 51.344 | Units per liter (U/L) | |
| Changes in Serum AST Levels | Sugar Pill | -56 | Full Range 18.243 | Units per liter (U/L) | |
| Changes in Serum SAM | S-adenosylmethionine (SAMe) | 54 | Full Range 92.535 | nmol/liter | |
| Changes in Serum SAM | Sugar Pill | 7 | Full Range 150.5 | nmol/liter |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-adenosylmethionine (SAMe) | 18 | |
| Overall Study | STARTED | Healthy | 28 | |
| Overall Study | STARTED | Sugar Pill | 19 | |
| Overall Study | STARTED | Lifestyle Counseling | 26 | |
| Overall Study | COMPLETED | S-adenosylmethionine (SAMe) | 13 | |
| Overall Study | COMPLETED | Healthy | 28 | |
| Overall Study | COMPLETED | Sugar Pill | 13 | |
| Overall Study | COMPLETED | Lifestyle Counseling | 26 | |
| Overall Study | NOT COMPLETED | S-adenosylmethionine (SAMe) | 5 | |
| Overall Study | NOT COMPLETED | Healthy | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
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 | Diarrhea | Gastrointestinal disorders | S-adenosylmethionine (SAMe) Treatment | 4 | 18 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Sugar Pill Placebo | 4 | 19 | 4 |
| other | Headache | Nervous system disorders | S-adenosylmethionine (SAMe) Treatment | 2 | 18 | 2 |
| other | Headache | Nervous system disorders | Sugar Pill Placebo | 0 | 19 | 0 |
| other | Abdominal bloating | Gastrointestinal disorders | S-adenosylmethionine (SAMe) Treatment | 3 | 18 | 3 |
| other | Abdominal bloating | Gastrointestinal disorders | Sugar Pill Placebo | 2 | 19 | 2 |
| other | Nausea | Gastrointestinal disorders | S-adenosylmethionine (SAMe) Treatment | 0 | 18 | 0 |
| other | Nausea | Gastrointestinal disorders | Sugar Pill Placebo | 2 | 19 | 2 |
| other | Night sweats, hair loss, xerostomia | Nervous system disorders | S-adenosylmethionine (SAMe) Treatment | 1 | 18 | 1 |
| other | Night sweats, hair loss, xerostomia | Nervous system disorders | Sugar Pill Placebo | 0 | 19 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-adenosylmethionine (SAMe) Treatment | ||
| Total, all-cause mortality | Sugar Pill Placebo | ||
| Total, other adverse events | S-adenosylmethionine (SAMe) Treatment | 10 | 18 |
| Total, other adverse events | Sugar Pill Placebo | 10 | 19 |
| Total, serious adverse events | S-adenosylmethionine (SAMe) Treatment | 0 | 18 |
| Total, serious adverse events | Sugar Pill Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R01AA014562 | EFFECTS OF SAM IN PATIENTS WITH ALCOHOLIC LIVER DISEASE | HALSTED, CHARLES HOPKINSON | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2005 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| S-adenosylmethionine (SAMe) Treatment vs Sugar Pill Placebo: serious adverse events |
Source 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.
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/NCT00573313
GET https://conductscience.org/api/trials/v1/NCT00573313/registered