NCT00253773

Brief Summary

This pilot study tests the feasibility of using GSH redox state and high resolution proton NMR spectroscopy (1H-NMR) to detect metabolic changes due to acetominophen and sulfur amino acid deficiency. Our central hypothesis is that the a 2-day sulfur amino acid deficiency will alter acetominophen metabolism, acetominophen will affect sulfur amino acid homeostasis, and the treatments together will alter the global metabolic profile, as measured by 1H-NMR spectroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

November 14, 2005

Last Update Submit

January 12, 2010

Conditions

Oxidative Stress

Keywords

sulfer amino acidsredox status

Outcome Measures

Primary Outcomes (1)

  • individual thiol and disulfide components; GSH/GSSG and Cys/CySS redox state; urinary output of taurine and sulfate

Interventions

acetominophen, sulfer amino acids; cysteine and methionineDRUG

Eligibility Criteria

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

You may qualify if:

  • healthy volunteers males and females

You may not qualify if:

  • acute/chronic illnesses age less than 18 and greater than 40 pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

AcetaminophenCysteineMethionine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAmino Acids, SulfurSulfur CompoundsSulfhydryl CompoundsAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Dean Jones, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

January 1, 2005

Study Completion

November 1, 2007

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(1)