Oxidative StressNCT02649777
Normal Values of Oxidative Stress, Taurine, and Related Markers
An observational study of Oxidative Stress, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. Read more about this study
- Who is it for?
- Ages 8 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2017
- Phase
- Observational
- 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 8 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy Individuals older than 8 years and less than 50 years
Who may be able to join
- Age: Over 8 years old and less than 50 years
Who cannot join
- Pregnancy: Females who are pregnant or lactating will be excluded from the study as the influence of pregnancy on the markers is not known nor is the impact of pregnancy on taurine known.
- Antioxidant use: Individuals taking taurine, over the counter energy drinks containing taurine or other high dose antioxidants such as Vitamin C or E, coenzyme Q, carotenes, selenium will be excluded as such intake will likely impact laboratory results.
- Inflammatory status:
- Individuals who have a significant chronic illness or state that has a known or suspected marked inflammatory component or oxidative stress component will be excluded from the study as the illness will impact inflammatory markers.
- Patients with an acute illness, which may impact inflammatory biomarkers, will be postponed for study entry until the acute illness is resolved. Entry into the study at a later day will be offered. The study visit will not be conducted within 3 weeks of the acute illness.
- Smoking within the past 12 months will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural occurring oxidative stress protectant. A primary and specific application of this data is for the evaluation of oxidative stress, levels of the natural protectant taurine, and of associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).
Read the detailed description
This study is a one-time collection of blood and urine samples in healthy individuals. Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of blood (1 and 1/5 teaspoon) and a urine sample will be collected.
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress marker: TBARS
Single Draw for one-time analysis
Measured: Time 0
Metabolite antioxidant: Taurine
Single Draw for one-time analysis
Measured: Time 0
Secondary outcomes (10)
Inflammation marker: Supper oxide dismutase (SOD)
Single Draw for one-time analysis
Measured: Time 0
Inflammation marker: TGFβ
Single Draw for one-time analysis
Measured: Time 0
Inflammation marker: myeloperoxidase
Single Draw for one-time analysis
Measured: time 0
Metabolites: S-adenosylmethionine and S-adenosylhomocysteine
Single Draw for one-time analysis (same units)
Measured: Time 0
Vascular function: Thromboxane B2 metabolites
Single Draw for one-time analysis (same units)
Measured: Time 0
Oxidative stress: dityrosine
Single Draw for one-time analysis
Measured: Time 0
Inflammation markers: IL1α, IL-1β, IL10, TNFα
Single Draw for one-time analysis; ELISA assay (same units)
Measured: Time 0
Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ
Single Draw for one-time analysis; Luminex assay (same units)
Measured: Time 0
Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12
Single Draw for one-time analysis; high sensitivity Luminex assay (same units)
Measured: Time 0
Inflammation marker: high sensitivity CRP
Single Draw for one-time analysis
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan LK Van Hove, MD, PhD, MBA, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649777
- Sponsor's protocol ID
- 15-2091
- Other IDs
- UL1TR001082
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Oxidative Stress, Taurine, and Related Markers
- ClinicalTrials.gov ID
- NCT02649777
- Acronym / sponsor ID
- 15-2091
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Jan 2016 (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.
The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural occurring oxidative stress protectant. A primary and specific application of this data is for the evaluation of oxidative stress, levels of the natural protectant taurine, and of associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).
Detailed description
This study is a one-time collection of blood and urine samples in healthy individuals. Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of blood (1 and 1/5 teaspoon) and a urine sample will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy Individuals older than 8 years and less than 50 years
Key inclusion criteria (1 listed)
- Age: Over 8 years old and less than 50 years
Key exclusion criteria (6 listed)
- Pregnancy: Females who are pregnant or lactating will be excluded from the study as the influence of pregnancy on the markers is not known nor is the impact of pregnancy on taurine known.
- Antioxidant use: Individuals taking taurine, over the counter energy drinks containing taurine or other high dose antioxidants such as Vitamin C or E, coenzyme Q, carotenes, selenium will be excluded as such intake will likely impact laboratory results.
- Inflammatory status:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxidative stress marker: TBARS
Time frame: Time 0
Single Draw for one-time analysis
Metabolite antioxidant: Taurine
Time frame: Time 0
Single Draw for one-time analysis
10 secondary outcomes
Inflammation marker: Supper oxide dismutase (SOD)
Time frame: Time 0
Inflammation marker: TGFβ
Time frame: Time 0
Inflammation marker: myeloperoxidase
Time frame: time 0
Metabolites: S-adenosylmethionine and S-adenosylhomocysteine
Time frame: Time 0
Vascular function: Thromboxane B2 metabolites
Time frame: Time 0
Oxidative stress: dityrosine
Time frame: Time 0
Inflammation markers: IL1α, IL-1β, IL10, TNFα
Time frame: Time 0
Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ
Time frame: Time 0
Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12
Time frame: Time 0
Inflammation marker: high sensitivity CRP
Time frame: Time 0
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 19 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Johan LK Van Hove, MD, PhD, MBA principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by University of Colorado, Denver 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 6 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 19 Jan 2018. 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?
Oxidative stress marker: TBARS (time frame: Time 0). The study lists 2 primary outcomes in all. 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 19 Jan 2018.