E-cigarettes, Oxidative Stress, InflammationNCT03823885
ECigs, Inflammation and Oxidative Stress
A study testing e-cigarette in people with E-cigarettes, Oxidative Stress, Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarettes, Oxidative Stress, Inflammation
- What is being tested?
- e-cigarette
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 1 Oct 2023
- Phase
- Interventional
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Cardiac disease Respiratory disease Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-Cigarettes and Monocytes
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.
Read the detailed description
Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.
- Being tested
- e-cigarette, empty (-cigarette sham control)
- Medical subject headings
- Vaping, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-cigaretteOther
Also called e-cig
use e-cig for 30 minutes
empty (-cigarette sham control)Other
Also called empty e-cig
use empty e-cig (sham control)
| Study group | Role | What they receive |
|---|---|---|
| E-cig | Experimental | One time exposure to e-cig Receives: Other: e-cigarette |
| sham | Experimental | One time exposure to empty e-cig Receives: Other: empty (-cigarette sham control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular Reactive Oxygen Species, units = % fluorescence
cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
Measured: within 4 hours of E-cig use
Secondary outcomes (1)
CD 14+ Monocyte, units = % of total cells
CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye
Measured: within 4 hours of e-cig use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start8 Feb 2019
- Primary completion8 Feb 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for E-cigarettes, Oxidative Stress, InflammationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover with 2 week washout
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823885
- Sponsor's protocol ID
- 18001147
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelesidis T, Tran E, Arastoo S, Lakhani K, Heymans R, Gornbein J, Middlekauff HR. Elevated Cellular Oxidative Stress in Circulating Immune Cells in Otherwise Healthy Young People Who Use Electronic Cigarettes in a Cross-Sectional Single-Center Study: Implications for Future Cardiovascular Risk. J Am Heart Assoc. 2020 Sep 15;9(18):e016983. doi: 10.1161/JAHA.120.016983. Epub 2020 Sep 8.
PubMed 32896211
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Cigarettes and Monocytes
- ClinicalTrials.gov ID
- NCT03823885
- Acronym / sponsor ID
- 18001147
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 31 Jan 2019 (actual)
- 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.
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.
Detailed description
Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover with 2 week washout
| Arm | Type | Receives |
|---|---|---|
| E-cig | Experimental | Other: e-cigaretteOne time exposure to e-cig |
| sham | Experimental | Other: empty (-cigarette sham control)One time exposure to empty e-cig |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Cardiac disease Respiratory disease Diabetes
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 |
|---|---|---|
| e-cigaretteAlso: e-ciguse e-cig for 30 minutes | Other | E-cig |
| empty (-cigarette sham control)Also: empty e-ciguse empty e-cig (sham control) | Other | sham |
Primary outcome
Cellular Reactive Oxygen Species, units = % fluorescence
Time frame: within 4 hours of E-cig use
cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
1 secondary outcome
CD 14+ Monocyte, units = % of total cells
Time frame: within 4 hours of e-cig use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 32896211Kelesidis T, Tran E, Arastoo S, Lakhani K, Heymans R, Gornbein J, Middlekauff HR. Elevated Cellular Oxidative Stress in Circulating Immune Cells in Otherwise Healthy Young People Who Use Electronic Cigarettes in a Cross-Sectional Single-Center Study: Implications for Future Cardiovascular Risk. J Am Heart Assoc. 2020 Sep 15;9(18):e016983. doi: 10.1161/JAHA.120.016983. Epub 2020 Sep 8.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-cigarette in people with E-cigarettes, Oxidative Stress, Inflammation, run by University of California, Los Angeles 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cellular Reactive Oxygen Species, units = % fluorescence (time frame: within 4 hours of E-cig use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823885, which also lists 1 linked publication.
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 4 Oct 2023.