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NCT04013412 · ClinicalTrials.gov registry record · NA
Dietary Restriction in Vascular Surgery
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04013412: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT04013412 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04013412, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. This study is a step in the long-term primary scientific objective to test the hypothesis that brief up regulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Primary Outcome
Patient compliance with the PCR diet will be assessed by food record analysis.
Interventions
- DIETARY_SUPPLEMENT Protein-Calorie Restriction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2020-03-31 |
| Phase | NA |
What the finished NCT04013412 record still lists
NCT04013412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Protein-Calorie Restriction is the first listed.
NCT04013412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04013412 about?
NCT04013412 is a clinical study titled "Dietary Restriction in Vascular Surgery". A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. This study is a step in the lo...
What is the current status of trial NCT04013412?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2018-12-31. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT04013412?
The interventions under investigation include: Protein-Calorie Restriction (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04013412?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04013412's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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