CClinicalTrials.gg
Status unknownNCT00303160Updated Aug 14, 2007

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

A Phase 4 interventional study of vitamin C & E supplements in Heliobacter Pylori Infection, sponsored by University of Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-08-14.

Sponsored by University of Toronto · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heliobacter Pylori Infection

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Keywords

  • heliobacter pylori infection
  • reactive oxygen species
  • antioxidants
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 72 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult , age 18-45

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Interventions

  • Drugvitamin C & E supplements
06

What researchers measure

Primary outcomes

  1. plasma vitamin C levels

  2. plasma vitamin E levels

Secondary outcomes

  1. TBARS levels

07

Study locations

1 site
  • Toronto General Hospital
    Toronto, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00303160
Lead sponsor
University of Toronto
Collaborators
CCERN: canadian cancer etiology research network
First posted
Mar 15, 2006
Start date
Mar 2006
Completion
Sep 2007 (estimated)
Last update
Aug 14, 2007

Study contacts

Farah Naja, MSc.
principal investigator · Canada: Cancer Care Ontario
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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