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CompletedNCT01038024Updated Mar 8, 2013

Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

An interventional study of 1 tablet composed of antioxidants and minerals in Cancer, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-08.

Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.

02

Conditions studied

  • Cancer

Keywords

  • antioxidant supplement
03

In context

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Health male or female non-melanoma patients or volunteers
  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Antioxidant Supplements

    Dietary Supplement: 1 tablet composed of antioxidants and minerals

Interventions

  • Dietary supplement1 tablet composed of antioxidants and minerals

    1 tablet daily

06

What researchers measure

Primary outcomes

  1. To establish a base line level for 5 DNA modifications of White blood cells

    Time frame: 2 years

07

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01038024
Lead sponsor
Roswell Park Cancer Institute
Responsible party
Sponsor
First posted
Dec 23, 2009
Start date
Jan 2010
Primary completion
Feb 2011
Completion
Jul 2012
Last update
Mar 8, 2013

Study contacts

Nathalie Zeitouni, MD
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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