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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:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00613392
First received: January 30, 2008
Last updated: October 4, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antioxidant Supplementation in Trauma Patients

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: November 2009
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613392

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

No publications provided

Responsible Party: Suresh Agarwal MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00613392     History of Changes
Other Study ID Numbers: H-25038
Study First Received: January 30, 2008
Last Updated: October 4, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013