Trial · NCT00237718
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
NCT00237718, Phase 2, Completed, Vanderbilt University; results first posted 2011-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Provision of Antioxidant Therapy in Hemodialysis (PATH) Study. Trials, record NCT00237718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00237718
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
- NCT number
- NCT00237718
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 385 participants, actual
- Lead sponsor
- Vanderbilt University
- Conditions
- End-stage Renal Disease
- Interventions
- Alpha, gamma, beta, and delta (mixed) tocopherols, Alpha lipoic acid, Placebo, Placebo
- First posted
- 2005-10-12
- Last updated
- 2012-01-11
- Results first posted
- 2011-10-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | F2-isoprostane (F2-iso) | month 6 | F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress. |
| Secondary | Interleukin-6 (IL-6) | month 6 | IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response. |
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 | F2-isoprostane (F2-iso) | month 6 | The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol. | ng/ml | MEAN |
| SECONDARY | Interleukin-6 (IL-6) | month 6 | The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol. | pg/ml | MEAN |
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 |
|---|---|---|---|---|---|
| F2-isoprostane (F2-iso) | ALA and Vitamin E | 0.077 | Standard Deviation 0.062 | ng/ml | |
| F2-isoprostane (F2-iso) | Placebo | 0.073 | Standard Deviation 0.055 | ng/ml | |
| Interleukin-6 (IL-6) | ALA and Vitamin E | 19 | Standard Deviation 15 | pg/ml | |
| Interleukin-6 (IL-6) | Placebo | 20 | Standard Deviation 27 | pg/ml |
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 | ALA and Vitamin E | 160 | |
| Overall Study | STARTED | Placebo | 165 | |
| Overall Study | COMPLETED | ALA and Vitamin E | 114 | |
| Overall Study | COMPLETED | Placebo | 124 | |
| Overall Study | NOT COMPLETED | ALA and Vitamin E | 46 | |
| Overall Study | NOT COMPLETED | Placebo | 41 |
Source ClinicalTrials.gov
Adverse events52
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 | GI upset | Gastrointestinal disorders | ALA and Vitamin E | 44 | 160 | 63 |
| other | GI upset | Gastrointestinal disorders | Placebo | 33 | 165 | 44 |
| other | infection | Infections and infestations | ALA and Vitamin E | 32 | 160 | 38 |
| other | infection | Infections and infestations | Placebo | 36 | 165 | 48 |
| other | access related | Vascular disorders | ALA and Vitamin E | 22 | 160 | 44 |
| other | access related | Vascular disorders | Placebo | 15 | 165 | 25 |
| other | pain | General disorders | ALA and Vitamin E | 14 | 160 | 18 |
| other | pain | General disorders | Placebo | 19 | 165 | 27 |
| other | viral infection | Infections and infestations | ALA and Vitamin E | 15 | 160 | 19 |
| other | viral infection | Infections and infestations | Placebo | 19 | 165 | 22 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALA and Vitamin E | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ALA and Vitamin E | 91 | 160 |
| Total, other adverse events | Placebo | 85 | 165 |
| Total, serious adverse events | ALA and Vitamin E | 44 | 160 |
| Total, serious adverse events | Placebo | 52 | 165 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ALA and Vitamin E vs 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/NCT00237718
GET https://conductscience.org/api/trials/v1/NCT00237718/events?page=2