NCT01037465

Brief Summary

The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects. The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

December 19, 2009

Last Update Submit

March 8, 2017

Conditions

Cardiovascular Disease

Keywords

endotheliumcell signalingN-acetylcysteinereactive oxygen species

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow-mediated dilation

    4 hours

Secondary Outcomes (1)

  • Blood markers of antioxidant capacity

    4 hours

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

N-acetylcysteine

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

N-acetylcysteineDRUG

N-acetylcysteine

N-acetylcysteine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sex: Male and Female subjects.
  • Age range: 21-65 years old.
  • Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
  • Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.

You may not qualify if:

  • Women with a positive urine beta HCG pregnancy test and lactating women.
  • Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
  • History of any cigarette smoking within one year of the study.
  • Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
  • Treatment with an investigational new drug within the last 30 days.
  • History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Naomi Hamburg, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2009

First Posted

December 23, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2015

Study Completion

March 26, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)