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

Primary Purpose

Heliobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
vitamin C & E supplements
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heliobacter Pylori Infection focused on measuring heliobacter pylori infection, reactive oxygen species, antioxidants

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult , age 18-45 Exclusion Criteria: 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

Sites / Locations

  • Toronto General Hospital

Outcomes

Primary Outcome Measures

plasma vitamin C levels
plasma vitamin E levels

Secondary Outcome Measures

TBARS levels

Full Information

First Posted
March 14, 2006
Last Updated
August 13, 2007
Sponsor
University of Toronto
Collaborators
CCERN: canadian cancer etiology research network
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1. Study Identification

Unique Protocol Identification Number
NCT00303160
Brief Title
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

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
CCERN: canadian cancer etiology research network

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heliobacter Pylori Infection
Keywords
heliobacter pylori infection, reactive oxygen species, antioxidants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
vitamin C & E supplements
Primary Outcome Measure Information:
Title
plasma vitamin C levels
Title
plasma vitamin E levels
Secondary Outcome Measure Information:
Title
TBARS levels

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult , age 18-45 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farah Naja, MSc.
Organizational Affiliation
Canada: Cancer Care Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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