Trial · NCT01285362
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
NCT01285362, Not applicable, Completed, Columbia University; results first posted 2022-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study. Trials, record NCT01285362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01285362
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
- NCT number
- NCT01285362
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 8 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Fish Oil Supplementation, Placebo Supplementation
- First posted
- 2011-01-28
- Last updated
- 2022-05-05
- Results first posted
- 2022-05-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Normalized Liver Enzyme Levels | Up to 12 months from entry into the study | To evaluate the number of participants (young adults with obesity related NAFLD) that will normalize their elevated liver enzyme levels (normalized defined as having liver enzyme levels within a normal laboratory range) with supplements of fish oil (n-3 FA containing eicosapentanoic acid and docosahexaenoic acid). |
| Secondary | Number of Participants With Normalization of Plasma Lipid Levels | Up to 12 months from entry into the study | The number of participants (young adults with obesity-related NAFLD and associated dyslipidemia) that will normalize plasma lipid levels (normalized defined as having plasma lipid levels within a normal laboratory range) after fish oil supplementation. |
| Secondary | Number of Participants With Insulin Resistance Attenuated | Up to 12 months from entry into the study | The number of participants (young adults with obesity related NAFLD and insulin resistance) that will attenuate insulin resistance (attenuation of insulin resistance defined as decrease in the body's need for insulin and measured by insulin levels and estimation of Homeostatic model assessment (HOMA-R) after fish oil supplementation. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Normalized Liver Enzyme Levels | Up to 12 months from entry into the study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Normalization of Plasma Lipid Levels | Up to 12 months from entry into the study | Plasma lipid levels were obtained for 6 participants (3 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Insulin Resistance Attenuated | Up to 12 months from entry into the study | Zero participants from group A were analyzed, as insulin levels were not collected at follow-up. Insulin levels were not collected at follow-up as insulin levels were within normal limits at baseline. Two participants in group B were analyzed; 2 of the 4 participants in group B had insulin levels collected at follow-up. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Normalized Liver Enzyme Levels | Fish Oil Supplementation (Group A) | 0 | Participants | ||
| Participants With Normalized Liver Enzyme Levels | Placebo Supplementation (Group B) | 0 | Participants | ||
| Number of Participants With Normalization of Plasma Lipid Levels | Fish Oil Supplementation (Group A) | 0 | Participants | ||
| Number of Participants With Normalization of Plasma Lipid Levels | Placebo Supplementation (Group B) | 0 | Participants | ||
| Number of Participants With Insulin Resistance Attenuated | Placebo Supplementation (Group B) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fish Oil Supplementation (Group A) | 4 | |
| Overall Study | STARTED | Placebo Supplementation (Group B) | 4 | |
| Overall Study | COMPLETED | Fish Oil Supplementation (Group A) | 4 | |
| Overall Study | COMPLETED | Placebo Supplementation (Group B) | 4 | |
| Overall Study | NOT COMPLETED | Fish Oil Supplementation (Group A) | 0 | |
| Overall Study | NOT COMPLETED | Placebo Supplementation (Group B) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fish Oil Supplementation (Group A) | 0 | 4 |
| Total, all-cause mortality | Placebo Supplementation (Group B) | 0 | 4 |
| Total, other adverse events | Fish Oil Supplementation (Group A) | 0 | 4 |
| Total, other adverse events | Placebo Supplementation (Group B) | 0 | 4 |
| Total, serious adverse events | Fish Oil Supplementation (Group A) | 0 | 4 |
| Total, serious adverse events | Placebo Supplementation (Group B) | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fish Oil Supplementation (Group A) vs Placebo Supplementation (Group B): Number of Participants With Normalization of Plasma Lipid Levels | Trial comparisons |
| Fish Oil Supplementation (Group A) vs Placebo Supplementation (Group B): Participants With Normalized Liver Enzyme Levels | Trial comparisons |
| Fish Oil Supplementation (Group A) vs Placebo Supplementation (Group B): deaths from any cause | Trial comparisons |
| Fish Oil Supplementation (Group A) vs Placebo Supplementation (Group B): 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.
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/NCT01285362
GET https://conductscience.org/api/trials/v1/NCT01285362/registered