NCT01905696

Brief Summary

Nitric oxide is believed to contribute to regulation of blood flow by its selective binding to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using oral N-acetylcysteine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2013

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

April 30, 2013

Last Update Submit

December 28, 2016

Conditions

Focus is Determination of the Role of SNO-Hb in Forearm Blood Flow Regulation

Outcome Measures

Primary Outcomes (1)

  • Forearm blood flow

    5 days

Study Arms (1)

N-Acetylcysteine (NAC)

EXPERIMENTAL

After initial measurements of SNO-Hb level, forearm blood flow in response to exercise and hypoxia, subjects will take oral NAC 600 mg twice daily. Measurements will then be repeated.

Drug: Oral N-acetylcysteine

Interventions

Oral N-acetylcysteineDRUG
N-Acetylcysteine (NAC)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Pregnancy
  • smoking
  • pulmonary disease
  • cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

July 23, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

US(1)