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Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD

NCT01335971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2017-05-19

Study results available
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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.

Conditions

  • COPD

Interventions

DRUG

Sulforaphane 25

25 micromoles (4.4 mg) sulforaphane daily by mouth

DIETARY_SUPPLEMENT

Sulforaphane 150

150 micromoles (26.6 mg) sulforaphane daily by mouth

OTHER

Placebo

Microcrystalline cellulose once daily by mouth

Sponsors & Collaborators

  • Temple University

    collaborator OTHER

  • State University of New York at Buffalo

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Janet T Holbrook, PhD, MPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-07-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335971 on ClinicalTrials.gov