Trial · NCT00064753
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
NCT00064753, Phase 2, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT). Trials, record NCT00064753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
- NCT number
- NCT00064753
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 4,110 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease, Death
- Interventions
- High Dose Multivitamin, Low Dose Multivitamin
- First posted
- 2003-07-15
- Last updated
- 2017-10-18
- Results first posted
- 2015-11-26
- Limitations and caveats
The B-vitamin pathway for reducing total homocysteine (tHcy) may not be the optimal one for reducing CVD risk. Also, the duration of follow-up may not have been sufficient to identify a lagged impact on modification of CVD risk.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events | Up to 6 years (mean 4 years) | |
| Secondary | Renal Graft Failure | Up to 6 years (mean 4 years) | |
| Secondary | Mortality (All-cause) | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Fatal/Non-fatal Myocardial Infarction (MI) | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Fatal/Non-fatal Stroke | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Resuscitated Sudden Death (RSD) | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | CVD Death | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Coronary Artery Revascularization | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Lower Extremity Peripheral Arterial Disease (PAD) | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
| Secondary | Carotid Endarterectomy or Angioplasty | Up to 6 years (mean 4 years) | censored at 3 months after return to dialysis |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events | Up to 6 years (mean 4 years) | Censored at 3 months after return to dialysis | participants | NUMBER |
| SECONDARY | Renal Graft Failure | Up to 6 years (mean 4 years) | Intention-to-treat | participants | NUMBER |
| SECONDARY | Mortality (All-cause) | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | Fatal/Non-fatal Myocardial Infarction (MI) | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | Fatal/Non-fatal Stroke | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | Resuscitated Sudden Death (RSD) | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | CVD Death | Up to 6 years (mean 4 years) | P was calculated with stratified proportional hazards models stratified by country | participants | NUMBER |
| SECONDARY | Coronary Artery Revascularization | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | Lower Extremity Peripheral Arterial Disease (PAD) | Up to 6 years (mean 4 years) | participants | NUMBER | |
| SECONDARY | Carotid Endarterectomy or Angioplasty | Up to 6 years (mean 4 years) | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events | High Dose Multivitamin | 269 | participants | ||
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events | Low Dose Multivitamin | 278 | participants | ||
| Renal Graft Failure | High Dose Multivitamin | 181 | participants | ||
| Renal Graft Failure | Low Dose Multivitamin | 162 | participants | ||
| Mortality (All-cause) | High Dose Multivitamin | 217 | participants | ||
| Mortality (All-cause) | Low Dose Multivitamin | 214 | participants | ||
| Fatal/Non-fatal Myocardial Infarction (MI) | High Dose Multivitamin | 90 | participants | ||
| Fatal/Non-fatal Myocardial Infarction (MI) | Low Dose Multivitamin | 86 | participants | ||
| Fatal/Non-fatal Stroke | High Dose Multivitamin | 35 | participants | ||
| Fatal/Non-fatal Stroke | Low Dose Multivitamin | 32 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose Multivitamin | 2,056 | |
| Overall Study | STARTED | Low Dose Multivitamin | 2,054 | |
| Overall Study | COMPLETED | High Dose Multivitamin | 1,382 | |
| Overall Study | COMPLETED | Low Dose Multivitamin | 1,406 | |
| Overall Study | NOT COMPLETED | High Dose Multivitamin | 674 | |
| Overall Study | NOT COMPLETED | Low Dose Multivitamin | 648 |
Source ClinicalTrials.gov
Adverse events2
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 | Gastrointestinal disturbances | Gastrointestinal disorders | High Dose Multivitamin | 121 | 2,056 | |
| other | Gastrointestinal disturbances | Gastrointestinal disorders | Low Dose Multivitamin | 114 | 2,054 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Multivitamin | ||
| Total, all-cause mortality | Low Dose Multivitamin | ||
| Total, other adverse events | High Dose Multivitamin | 121 | 2,056 |
| Total, other adverse events | Low Dose Multivitamin | 114 | 2,054 |
| Total, serious adverse events | High Dose Multivitamin | 0 | 2,056 |
| Total, serious adverse events | Low Dose Multivitamin | 0 | 2,054 |
Source ClinicalTrials.gov
Papers11
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 |
|---|---|---|---|---|---|
| U01DK061700 | Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial | LEVEY, ANDREW S | TUFTS MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2001 to 2011 |
Source NIH RePORTER
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose Multivitamin vs Low Dose Multivitamin: Resuscitated Sudden Death (RSD) | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Carotid Endarterectomy or Angioplasty | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Fatal/Non-fatal Myocardial Infarction (MI) | Trial comparisons |
High Dose Multivitamin vs Low Dose Multivitamin: Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: CVD Death | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Renal Graft Failure | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Lower Extremity Peripheral Arterial Disease (PAD) | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Fatal/Non-fatal Stroke | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Abdominal Aortic Aneurysm Repair | Trial comparisons |
| High Dose Multivitamin vs Low Dose Multivitamin: Mortality (All-cause) | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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/NCT00064753
GET https://conductscience.org/api/trials/v1/NCT00064753/results?page=2