Multiple TraumaPhase 1/2NCT01477697
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
A Phase 1/2 study testing Omega-3 in people with Multiple Trauma, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2012
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multi-system blunt trauma patients
- Ages 18 through 65 years, inclusive
- Admission to ICU
- Nasogastric or nasoenteric feeding tube in place
- Intention of primary medical team to feed the patient enterally
Who cannot join
- Expected mortality within 48 hours
- Intracranial hemorrhage
- Pregnant or breast feeding
- Patient, surrogate, or physician not committed to full support
- Refractory shock
- Unable to obtain enteral access
Show all 10Show fewer
- Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction
- Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days
- Current gastrointestinal bleeding
- Requirement for vasopressors
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo
Read the detailed description
This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.
- Conditions
- Multiple Trauma
- Being tested
- Omega-3, Placebo
- Keywords
- Trauma
- 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.
Omega-3Dietary supplement
50 mg/kg per day of omega-3 fatty acids
PlaceboDietary supplement
50 mg/kg per day of placebo equivalent
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | 50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD) Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | 50 mg/kg per day of vehicle Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein
Measured: Up to 28 days
Secondary outcomes (2)
Infectious complications
Incidence of infectious disease complications using established diagnostic criteria
Measured: Up to 28 days
Intensive Care Unit length of stay
A count of the number of days during which patients are resident in the Surgical Intensive Care Unit
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.
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.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishna Athota, University of Cincinnati
- Investigators
- Krishna Athota, MD, Principal investigator, University of CincinnatiRichard Branson, MSc, Study director, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477697
- Sponsor's protocol ID
- Athota-2010-01
- Status last verified
- Feb 2013
- First submitted
- 18 Nov 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
- ClinicalTrials.gov ID
- NCT01477697
- Acronym / sponsor ID
- Athota-2010-01
- Conditions
- Multiple Trauma
- Keywords
- Trauma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Nov 2011 (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.
This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo
Detailed description
This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega-350 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo50 mg/kg per day of vehicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multi-system blunt trauma patients
- Ages 18 through 65 years, inclusive
- Admission to ICU
- Nasogastric or nasoenteric feeding tube in place
- Intention of primary medical team to feed the patient enterally
Key exclusion criteria (10 listed)
- Expected mortality within 48 hours
- Intracranial hemorrhage
- Pregnant or breast feeding
- Patient, surrogate, or physician not committed to full support
- Refractory shock
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 |
|---|---|---|
| Omega-350 mg/kg per day of omega-3 fatty acids | Dietary supplement | Omega-3 |
| Placebo50 mg/kg per day of placebo equivalent | Dietary supplement | Placebo |
Primary outcome
Inflammatory markers
Time frame: Up to 28 days
Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein
2 secondary outcomes
Infectious complications
Time frame: Up to 28 days
Intensive Care Unit length of stay
Time frame: Up to 28 days
Results and safety
The study was stopped early (reason given: Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
Related trials for Multiple Trauma
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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.
Krishna Athota, MD principal investigator
University of Cincinnati
Richard Branson, MSc study director
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omega-3 in people with Multiple Trauma, run by University of Cincinnati at 1 site in United States.
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 5 inclusion and 10 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.). 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?
Inflammatory markers (time frame: Up to 28 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 25 Feb 2013.