Antioxidant Supplementation in Trauma Patients - Full Text View

Antioxidant Supplementation in Trauma Patients

This study is currently recruiting participants.
Verified by Boston Medical Center, January 2008

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 Injuries Stress Wounds

Drug Information available for:

Starch

U.S. FDA Resources

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	lorrie.young@bmc.org

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

Responsible Party:	Boston Medical Center ( Suresh Agarwal MD )
Study ID Numbers:	H-25038
First Received:	January 30, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00613392
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

Wounds and Injuries

Disorders of Environmental Origin

Stress

ClinicalTrials.gov processed this record on October 23, 2008