Multiple TraumaPhase 3NCT00613392
Antioxidant Supplementation in Trauma Patients
A Phase 3 study testing powdered antioxidant in people with Multiple Trauma, run by Boston Medical Center.
Trial summary
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- powdered antioxidant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult non pregnant non lactating trauma patient
Who cannot join
- 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
About this study
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood
- Conditions
- Multiple Trauma
- Being tested
- powdered antioxidant, powdered cornstarch placebo
- Keywords
- antioxidant, oxidant stress, trauma, free radical
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powdered antioxidantDietary supplement
one vial mixed with water every day orally or through enteral tube
powdered cornstarch placeboDietary supplement
one vial mix with water and administer orally or via enteral tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: powdered antioxidant |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: powdered cornstarch placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
measures of malondialdehyde level/total antioxidant status and F2 isoprostane
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Supplement expired and unable to obtain more from company manufacturing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Burke, MD, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613392
- Sponsor's protocol ID
- H-25038
- Status last verified
- Oct 2010
- First submitted
- 30 Jan 2008
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Supplementation in Trauma Patients
- ClinicalTrials.gov ID
- NCT00613392
- Acronym / sponsor ID
- H-25038
- Conditions
- Multiple Trauma
- Keywords
- antioxidant, oxidant stress, trauma, free radical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Supplement expired and unable to obtain more from company manufacturing
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: powdered antioxidant |
| 2 | Placebo comparator | Dietary Supplement: powdered cornstarch placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult non pregnant non lactating trauma patient
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| powdered antioxidantone vial mixed with water every day orally or through enteral tube | Dietary supplement | 1 |
| powdered cornstarch placeboone vial mix with water and administer orally or via enteral tube | Dietary supplement | 2 |
Primary outcome
measures of malondialdehyde level/total antioxidant status and F2 isoprostane
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Supplement expired and unable to obtain more from company manufacturing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Burke, MD study director
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing powdered antioxidant in people with Multiple Trauma, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Supplement expired and unable to obtain more from company manufacturing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measures of malondialdehyde level/total antioxidant status and F2 isoprostane (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.