Antioxidant Supplementation in Trauma Patients

Phase 3

Terminated

• Conditions: Multiple Trauma
• Interventions: Dietary Supplement: powdered antioxidant; Dietary Supplement: powdered cornstarch placebo

• Registration Number: NCT00613392
• Lead Sponsor: Boston Medical Center

Brief Summary

Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-13
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-10
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	powdered antioxidant	-
2	powdered cornstarch placebo	-

Primary Outcome Measures

Name	Time	Method
measures of malondialdehyde level/total antioxidant status and F2 isoprostane	7 days