Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01335971 · ClinicalTrials.gov registry record · Phase 2
Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT01335971: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01335971 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335971, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study Summary
Evidence from investigators' group has shown that chronic obstructive pulmonary disease (COPD) patients have impairment of antioxidant defenses which are caused by a defect in activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables, which is a potent stimulator of Nrf2 activity. The investigators want to investigate whether ingestion of sulforaphane by COPD patients will increase Nrf2 activity and expression of downstream antioxidants. Accordingly, the investigators are conducting a placebo-controlled randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles, for 4 weeks in 90 COPD patients. The investigators' goal is to establish a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will have a novel candidate treatment for longer-term efficacy trials.
Primary Outcome
The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Interventions
- OTHER Placebo
- DRUG Sulforaphane 25
- DIETARY_SUPPLEMENT Sulforaphane 150
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01335971 record still lists
NCT01335971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01335971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335971 about?
NCT01335971 is a clinical study titled "Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD". Evidence from investigators' group has shown that chronic obstructive pulmonary disease (COPD) patients have impairment of antioxidant defenses which are caused by a defect in activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables, which is a potent stimulator o...
What is the current status of trial NCT01335971?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2010-09. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01335971?
The interventions under investigation include: Placebo (OTHER), Sulforaphane 25 (DRUG), Sulforaphane 150 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01335971?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01335971's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03682289 · 89 participants · Phase 2
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
- NCT04787939 · 89 participants · NA
Early Feeding After Oral Cavity Reconstruction
- NCT05480449 · 89 participants · Phase 1
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
- NCT05604131 · 89 participants · Phase 2
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia