Antioxidant Supplementation in Trauma Patients

January 25, 2016 updated by: Boston Medical Center
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult non pregnant non lactating trauma patient

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dietary supplement: powdered antioxidant
one vial mixed with water every day orally or through enteral tube
Placebo Comparator: 2
Dietary supplement: powdered cornstarch placebo
one vial mix with water and administer orally or via enteral tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measures of malondialdehyde level/total antioxidant status and F2 isoprostane
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Study Director: Peter Burke, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-25038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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