Effect of Helicobacter Pylori on the Availability of Vita... | NCT00303160

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

NCT00303160

Sponsor

University of Toronto

Status

Unknown status

Last Update Posted

Aug 14, 2007Estimated

Enrollment

72Estimated

Phase

Phase 4

Conditions

Heliobacter Pylori Infection

Interventions

vitamin C & E supplements

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007Estimated

First Submitted Date

Mar 14, 2006

First Submission Date that Met QC Criteria

Mar 14, 2006

First Posted Date

Mar 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2007

Last Update Posted Date

Aug 14, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of TorontoOTHER

Collaborators

Name	Class
CCERN: canadian cancer etiology research network	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Name	Type	Description	Arm Group Labels	Other Names
vitamin C & E supplements	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma vitamin C levels
plasma vitamin E levels

Secondary Outcomes

Measure	Description	Time Frame
TBARS levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Farah Naja, MSc.	Canada: Cancer Care Ontario	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto General Hospital		Toronto	Ontario		Canada

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

Not provided