Antioxidant Supplementation in Trauma Patients | NCT00613392

Studies
Antioxidant Supplementation in Trauma Patients

NCT00613392

Sponsor

Boston Medical Center

Status

Terminated

Last Update Posted

Jan 26, 2016Estimated

Enrollment

18Actual

Phase

Phase 3

Conditions

Multiple Trauma

Interventions

powdered antioxidant
powdered cornstarch placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Supplement expired and unable to obtain more from company manufacturing

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jan 30, 2008

First Submission Date that Met QC Criteria

Feb 11, 2008

First Posted Date

Feb 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Dietary Supplement: powdered antioxidant
2	Placebo Comparator		Dietary Supplement: powdered cornstarch placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
powdered antioxidant	Dietary Supplement	one vial mixed with water every day orally or through enteral tube	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measures of malondialdehyde level/total antioxidant status and F2 isoprostane		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter Burke, MD	Boston Medical Center	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009104	Multiple Trauma
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided