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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
CCERN: canadian cancer etiology research network
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00303160
First received: March 14, 2006
Last updated: August 13, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Heliobacter Pylori Infection
Drug: vitamin C & E supplements
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Helicobacter Pylori on the Availability of Vitamin E and C

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • plasma vitamin C levels
  • plasma vitamin E levels

Secondary Outcome Measures:
  • TBARS levels

Estimated Enrollment: 72
Study Start Date: March 2006
Estimated Study Completion Date: September 2007
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303160

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Toronto
CCERN: canadian cancer etiology research network
Investigators
Principal Investigator: Farah Naja, MSc. Canada: Cancer Care Ontario
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00303160     History of Changes
Other Study ID Numbers: 15344
Study First Received: March 14, 2006
Last Updated: August 13, 2007
Health Authority: Canada: University of Toronto
Canada: Toronto General Hospital

Keywords provided by University of Toronto:
heliobacter pylori infection
reactive oxygen species
antioxidants

Additional relevant MeSH terms:
Ascorbic Acid
Vitamin E
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014