Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014