Antioxidant Supplementation in Trauma Patients

This study is currently recruiting participants.

Verified by Boston Medical Center, January 2008

First Received: January 30, 2008 Last Updated: February 11, 2008 History of Changes

Sponsored by:	Boston Medical Center
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00613392

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 III

MedlinePlus related topics: Antioxidants Dietary Supplements Diets Injuries Wounds

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Antioxidant Supplementation in Trauma Patients

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 ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Dietary Supplement: powdered antioxidant one vial mixed with water every day orally or through enteral tube
2: Placebo Comparator	Dietary Supplement: powdered cornstarch placebo one vial mix with water and administer orally or via enteral tube

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613392

Contacts

Contact: Lorraine S Young, RD,MS

617-638-8597

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Lorraine S Young, RD,MS 617-638-8597 Lorrie.young@bmc.org

Sponsors and Collaborators

Boston Medical Center

Investigators

Study Director:

Peter Burke, MD

Boston Medical Center

More Information

No publications provided

Responsible Party:	Boston Medical Center ( Suresh Agarwal MD )
Study ID Numbers:	H-25038
Study First Received:	January 30, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00613392 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Medical Center:

antioxidant
oxidant stress
trauma
free radical

Study placed in the following topic categories:

Multiple Trauma
Antioxidants
Wounds and Injuries
Disorders of Environmental Origin
Stress

Additional relevant MeSH terms:

Multiple Trauma
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Wounds and Injuries
Disorders of Environmental Origin
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009