Heliobacter Pylori InfectionPhase 4NCT00303160
Effect of Helicobacter Pylori on the Availability of Vitamin E and C
A Phase 4 study testing vitamin C & E supplements in people with Heliobacter Pylori Infection, run by University of Toronto at 1 site in Canada.
Trial summary
This study argues that H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heliobacter Pylori Infection
- What is being tested?
- vitamin C & E supplements
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Sep 2007
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult , age 18-45
Who cannot join
- Smoking
- Body mass index below 18 or above 25.
- Previous treatment for H.pylori infection
- Partial or total gastrectomy
- History of gastritis
- Currently taking antioxidants supplementation
- Training in an athletic team.
- Drinking more than 3 servings of alcohol/day
Trial locations and contacts
1 site in 1 country.
About this study
This study argues that H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer.
Read the detailed description
It has been postulated that dietary antioxidants may reduce cancer risk by modulating red-ox status, by preventing biological oxidation, and by inhibiting the formation of carcinogen. However, supplementation studies and prospective studies have yielded contradictory results. In the case of gastric cancer, H.pylori infection, which is known to be associated with a higher risk of the disease, results in an increased production of ROS \& RNS. As a result serum levels of these free radicals increase, exerting a higher demand for dietary antioxidants to neutralize them.
The fact that the relation between serum levels of antioxidants and gastric cancer is more consistent than that of dietary intake levels and the disease suggests the possibility of the presence of an intrinsic factor that is altering the true relation between dietary antioxidants and the cancer. This intrinsic factor, this study argues, is the infection with H.pylori.
H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer. The purpose of this pilot study is to investigate the possibility that H.pylori infection alters the bioavailability of the dietary antioxidants: vitamin C, and vitamin E. This project will be done in preparation for an etiologic study of dietary antioxidants and gastric cancer.
- Conditions
- Heliobacter Pylori Infection
- Being tested
- vitamin C & E supplements
- Keywords
- heliobacter pylori infection, reactive oxygen species, antioxidants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin C & E supplementsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma vitamin C levels
plasma vitamin E levels
Secondary outcomes (1)
TBARS levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heliobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- CCERN: canadian cancer etiology research network
- Investigators
- Farah Naja, MSc., Principal investigator, Canada: Cancer Care Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303160
- Sponsor's protocol ID
- 15344
- Status last verified
- Aug 2007
- First submitted
- 14 Mar 2006
- Last updated
- 14 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori on the Availability of Vitamin E and C
- ClinicalTrials.gov ID
- NCT00303160
- Acronym / sponsor ID
- 15344
- Conditions
- Heliobacter Pylori Infection
- Keywords
- heliobacter pylori infection, reactive oxygen species, antioxidants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- CCERN: canadian cancer etiology research network
- Study start
- Mar 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 15 Mar 2006 (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 argues that H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer.
Detailed description
It has been postulated that dietary antioxidants may reduce cancer risk by modulating red-ox status, by preventing biological oxidation, and by inhibiting the formation of carcinogen. However, supplementation studies and prospective studies have yielded contradictory results. In the case of gastric cancer, H.pylori infection, which is known to be associated with a higher risk of the disease, results in an increased production of ROS \& RNS. As a result serum levels of these free radicals increase, exerting a higher demand for dietary antioxidants to neutralize them.
The fact that the relation between serum levels of antioxidants and gastric cancer is more consistent than that of dietary intake levels and the disease suggests the possibility of the presence of an intrinsic factor that is altering the true relation between dietary antioxidants and the cancer. This intrinsic factor, this study argues, is the infection with H.pylori.
H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer. The purpose of this pilot study is to investigate the possibility that H.pylori infection alters the bioavailability of the dietary antioxidants: vitamin C, and vitamin E. This project will be done in preparation for an etiologic study of dietary antioxidants and gastric cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult , age 18-45
Key exclusion criteria (8 listed)
- Smoking
- Body mass index below 18 or above 25.
- Previous treatment for H.pylori infection
- Partial or total gastrectomy
- History of gastritis
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 C & E supplements | Drug | – |
Primary outcome
plasma vitamin C levels
plasma vitamin E levels
1 secondary outcome
TBARS levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2007.
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.
Farah Naja, MSc. principal investigator
Canada: Cancer Care Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin C & E supplements in people with Heliobacter Pylori Infection, run by University of Toronto at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 14 Aug 2007. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
plasma vitamin C levels. 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 14 Aug 2007.