Antioxidant Supplementation in Trauma Patients

Multiple Trauma Clinical Trial

Official title:

Antioxidant Supplementation in Trauma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00613392
• Other study ID #: H-25038
• Status: Terminated
• Phase: Phase 3
• First received: January 30, 2008
• Last updated: January 25, 2016
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: October 2010
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Trauma
• Wounds and Injuries

Intervention

Dietary Supplement:
• powdered antioxidant
one vial mixed with water every day orally or through enteral tube
• powdered cornstarch placebo
one vial mix with water and administer orally or via enteral tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measures of malondialdehyde level/total antioxidant status and F2 isoprostane		7 days	No