NCT00613392

Brief Summary

Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 26, 2016

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

January 30, 2008

Last Update Submit

January 25, 2016

Conditions

Multiple Trauma

Keywords

antioxidantoxidant stresstraumafree radical

Outcome Measures

Primary Outcomes (1)

  • measures of malondialdehyde level/total antioxidant status and F2 isoprostane

    7 days

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: powdered antioxidant

2

PLACEBO COMPARATOR
Dietary Supplement: powdered cornstarch placebo

Interventions

powdered antioxidantDIETARY_SUPPLEMENT

one vial mixed with water every day orally or through enteral tube

1
powdered cornstarch placeboDIETARY_SUPPLEMENT

one vial mix with water and administer orally or via enteral tube

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult non pregnant non lactating trauma patient

You may not qualify if:

  • GCS \<6
  • Renal dysfunction (cre \> 2.5 mg/dl)
  • Hepatic dysfunction ( TBili \> 3.0 mg/dl)
  • Expected survival \< 48 hours
  • Burns over \> 20% body surface area
  • Immune-deficiency syndromes
  • Steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple TraumaWounds and Injuries

Study Officials

  • Peter Burke, MD

    Boston Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 13, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 26, 2016

Record last verified: 2010-10