NCT00309439

Brief Summary

The problem is the lack of data from randomized controlled trials to throw light on the ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer, namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on PSA would go a considerable way to providing the required evidence that ALA in the human diet has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction. hypothesis: The effect of ALA on PSA levels over time will be no different from the control, so providing supportive data for the view that ALA is not cancer promoting.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

First QC Date

March 29, 2006

Last Update Submit

June 12, 2012

Conditions

Atrial FibrillationDiet TherapyProstate Cancer

Interventions

ALA-rich dietPROCEDURE

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood samples available from Bordeaux

You may not qualify if:

  • Blood samples not received from Bordeaux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationProstatic Neoplasms

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • David JA Jenkins

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 31, 2006

Last Updated

June 13, 2012

Record last verified: 2012-06