Effect of Helicobacter Pylori on the Availability of Vitamin E and C

NCT ID: NCT00303160

Last Updated: 2007-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heliobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamin C & E supplements

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult , age 18-45

Exclusion Criteria

1. Smoking
2. Body mass index below 18 or above 25.
3. Previous treatment for H.pylori infection
4. Partial or total gastrectomy
5. History of gastritis
6. Currently taking antioxidants supplementation
7. Training in an athletic team.
8. Drinking more than 3 servings of alcohol/day
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CCERN: canadian cancer etiology research network

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Farah Naja, MSc.

Role: PRINCIPAL_INVESTIGATOR

Canada: Cancer Care Ontario

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15344

Identifier Type: -

Identifier Source: org_study_id