Back to results

Antioxidant Supplementation in Trauma Patients

Primary Purpose

Multiple Trauma

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

powdered antioxidant

powdered cornstarch placebo

About this trial

This is an interventional prevention trial for Multiple Trauma focused on measuring antioxidant, oxidant stress, trauma, free radical

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

measures of malondialdehyde level/total antioxidant status and F2 isoprostane

Secondary Outcome Measures

Full Information

NCT ID

NCT00613392

First Posted

January 30, 2008

Last Updated

January 25, 2016

Sponsor

Boston Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00613392

Brief Title

Antioxidant Supplementation in Trauma Patients

Official Title

Antioxidant Supplementation in Trauma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Terminated

Why Stopped

Supplement expired and unable to obtain more from company manufacturing

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Trauma

Keywords

antioxidant, oxidant stress, trauma, free radical

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

powdered antioxidant

Intervention Description

one vial mixed with water every day orally or through enteral tube

Intervention Type

Dietary Supplement

Intervention Name(s)

powdered cornstarch placebo

Intervention Description

one vial mix with water and administer orally or via enteral tube

Primary Outcome Measure Information:

Title

measures of malondialdehyde level/total antioxidant status and F2 isoprostane

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Burke, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Antioxidant Supplementation in Trauma Patients

We'll reach out to this number within 24 hrs