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Antioxidant Supplementation in Trauma Patients

This study has been terminated.
(Supplement expired and unable to obtain more from company manufacturing)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613392
First Posted: February 13, 2008
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Medical Center
  Purpose
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Condition Intervention Phase
Multiple Trauma Dietary Supplement: powdered antioxidant Dietary Supplement: powdered cornstarch placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antioxidant Supplementation in Trauma Patients

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • measures of malondialdehyde level/total antioxidant status and F2 isoprostane [ Time Frame: 7 days ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613392


Sponsors and Collaborators
Boston Medical Center
Investigators
Study Director: Peter Burke, MD Boston Medical Center
  More Information

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00613392     History of Changes
Other Study ID Numbers: H-25038
First Submitted: January 30, 2008
First Posted: February 13, 2008
Last Update Posted: January 26, 2016
Last Verified: October 2010

Keywords provided by Boston Medical Center:
antioxidant
oxidant stress
trauma
free radical

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Trauma
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs