Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Jan 2010
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 8, 2013
March 1, 2013
1.1 years
December 18, 2009
March 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To establish a base line level for 5 DNA modifications of White blood cells
2 years
Study Arms (1)
Antioxidant Supplements
EXPERIMENTALInterventions
1 tablet daily
Eligibility Criteria
You may qualify if:
- Health male or female non-melanoma patients or volunteers
- years or older with a life expectancy greater than 6 months
- Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
- Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
- Must have never smoked or has not smoked for at least 6 months
- Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form
You may not qualify if:
- Patients/healthy volunteers not meeting all of the above selection criteria.
- Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
- Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
- Patients not willing to comply with protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Zeitouni, MD
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 23, 2009
Study Start
January 1, 2010
Primary Completion
February 1, 2011
Study Completion
July 1, 2012
Last Updated
March 8, 2013
Record last verified: 2013-03