Clinical trial NCT00303160: Effect of Helicobacter Pylori on the Availability of Vitamin E and C
Official title: Effect of Helicobacter Pylori on the Availability of Vitamin E and C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heliobacter Pylori Infection
Keywords: heliobacter pylori infection
reactive oxygen species
antioxidants
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: CCERN: canadian cancer etiology research network
First posted: 2006-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma vitamin C levels
measure: plasma vitamin E levels
Secondary outcomes:
measure: TBARS levels
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Canada: Cancer Care Ontario
name: Farah Naja, MSc.
role: PRINCIPAL_INVESTIGATOR
References: