SmokingPhase 2NCT00067899
Oxidative Stress and Vitamin E Requirements
A Phase 2 study testing Vitamin E with and without Vitamin C in people with Smoking, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Vitamin E with and without Vitamin C
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Dec 2005
- Phase
- Phase 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking status or smokers (more than 1 pack per day)
- age: 18-35 y
- stable body weight, ranging between 80% and 130%,
- maintenance of normal exercise and activity patterns
- total cholesterol ≤ 7.758 mmol/L (300 mg/dl)
- triglyceride concentration ≤ 3.387 mmol/L (300 mg/dl)
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- Subjects will be excluded if they fulfill any one of the following:
- antioxidant supplement users
- resting blood pressure above 160/105 mm Hg
- engaged in aerobic activity more than five hours per week
- vegetarian or other restrictive dietary requirements
- fasting blood glucose concentration of ≥ 7.77 mmol/L (140 mg/dl)
- history of diabetes or uremia
- other known metabolic disease or medication use known to affect lipid metabolism
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Linus Pauling Institute - Oregon State University
Corvallis, Oregon, 97331
About this study
The purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.
Read the detailed description
We will be investigating the fractional disappearance rate of tocopherols in cigarette smokers compared to nonsmokers. This will be accomplished by supplementing individuals with deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well as urinary metabolites, alpha- and gamma-carboxy ethyl hydroxychromanol, will be determined using liquid chromatography/mass spectrometry analysis. In addition, the role of vitamin C as it pertains to its influence on the fraction disappearance rate of vitamin E will also be evaluated.
- Conditions
- Smoking
- Being tested
- Vitamin E with and without Vitamin C
- Keywords
- cigarette smoking, tocopherol, bioavailability, metabolism, oxidative stress
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E with and without Vitamin CDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2003 (estimated)
- Study startSep 2000
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 99 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Maret Traber, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067899
- Sponsor's protocol ID
- OSVER (completed)
- Status last verified
- Jun 2013
- First submitted
- 29 Aug 2003
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Traber MG, Winklhofer-Roob BM, Roob JM, Khoschsorur G, Aigner R, Cross C, Ramakrishnan R, Brigelius-Flohe R. Vitamin E kinetics in smokers and nonsmokers. Free Radic Biol Med. 2001 Dec 1;31(11):1368-74. doi: 10.1016/s0891-5849(01)00723-7.
PubMed 11728808Dietrich M, Block G, Norkus EP, Hudes M, Traber MG, Cross CE, Packer L. Smoking and exposure to environmental tobacco smoke decrease some plasma antioxidants and increase gamma-tocopherol in vivo after adjustment for dietary antioxidant intakes. Am J Clin Nutr. 2003 Jan;77(1):160-6. doi: 10.1093/ajcn/77.1.160.
PubMed 12499336Traber MG, van der Vliet A, Reznick AZ, Cross CE. Tobacco-related diseases. Is there a role for antioxidant micronutrient supplementation? Clin Chest Med. 2000 Mar;21(1):173-87, x. doi: 10.1016/s0272-5231(05)70016-2.
PubMed 10763098
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Vitamin E Requirements
- ClinicalTrials.gov ID
- NCT00067899
- Acronym / sponsor ID
- OSVER (completed)
- Conditions
- Smoking
- Keywords
- cigarette smoking, tocopherol, bioavailability, metabolism, oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 8 Sep 2003 (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 purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.
Detailed description
We will be investigating the fractional disappearance rate of tocopherols in cigarette smokers compared to nonsmokers. This will be accomplished by supplementing individuals with deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well as urinary metabolites, alpha- and gamma-carboxy ethyl hydroxychromanol, will be determined using liquid chromatography/mass spectrometry analysis. In addition, the role of vitamin C as it pertains to its influence on the fraction disappearance rate of vitamin E will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- non-smoking status or smokers (more than 1 pack per day)
- age: 18-35 y
- stable body weight, ranging between 80% and 130%,
- maintenance of normal exercise and activity patterns
- total cholesterol ≤ 7.758 mmol/L (300 mg/dl)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vitamin E with and without Vitamin C | Drug | – |
Primary outcome
Not reported in the source record.
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 Jun 2013.
- Background: PubMed 11728808Traber MG, Winklhofer-Roob BM, Roob JM, Khoschsorur G, Aigner R, Cross C, Ramakrishnan R, Brigelius-Flohe R. Vitamin E kinetics in smokers and nonsmokers. Free Radic Biol Med. 2001 Dec 1;31(11):1368-74. doi: 10.1016/s0891-5849(01)00723-7.
- Background: PubMed 12499336Dietrich M, Block G, Norkus EP, Hudes M, Traber MG, Cross CE, Packer L. Smoking and exposure to environmental tobacco smoke decrease some plasma antioxidants and increase gamma-tocopherol in vivo after adjustment for dietary antioxidant intakes. Am J Clin Nutr. 2003 Jan;77(1):160-6. doi: 10.1093/ajcn/77.1.160.
- Background: PubMed 10763098Traber MG, van der Vliet A, Reznick AZ, Cross CE. Tobacco-related diseases. Is there a role for antioxidant micronutrient supplementation? Clin Chest Med. 2000 Mar;21(1):173-87, x. doi: 10.1016/s0272-5231(05)70016-2.
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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.
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 Phase 2 study testing Vitamin E with and without Vitamin C in people with Smoking, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 14 inclusion and 0 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 Jun 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. 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 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067899, which also lists 3 linked publications.
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 Jun 2013.