ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00303160
Recruitment Status : Unknown
Verified August 2007 by University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2006
Last Update Posted : August 14, 2007
Sponsor:
Collaborator:
CCERN: canadian cancer etiology research network
Information provided by:
University of Toronto

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.

Condition or disease Intervention/treatment Phase
Heliobacter Pylori Infection Drug: vitamin C & E supplements Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Helicobacter Pylori on the Availability of Vitamin E and C
Study Start Date : March 2006
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E
Drug Information available for: Vitamin E




Primary Outcome Measures :
  1. plasma vitamin C levels
  2. plasma vitamin E levels

Secondary Outcome Measures :
  1. TBARS levels


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00303160     History of Changes
Other Study ID Numbers: 15344
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: August 14, 2007
Last Verified: August 2007

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

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