Overview

This trial is active, not recruiting.

Condition heliobacter pylori infection
Treatment vitamin c & e supplements
Phase phase 4
Sponsor University of Toronto
Collaborator CCERN: canadian cancer etiology research network
Start date March 2006
End date September 2007
Trial size 72 participants
Trial identifier NCT00303160, 15344

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
plasma vitamin C levels
time frame:
plasma vitamin E levels
time frame:

Secondary Outcomes

Measure
TBARS levels
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Effect of Helicobacter Pylori on the Availability of Vitamin E and C
Principal investigator Farah Naja, MSc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2007.
Information provided to ClinicalTrials.gov by University of Toronto.