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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Cancer

Treatments: Dietary Supplement: 1 tablet composed of antioxidants and minerals

Study type: Interventional

Funder types: Other

Identifiers

NCT01038024

I 155409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Antioxidant Supplements

Experimental group

Treatment:

Dietary Supplement: 1 tablet composed of antioxidants and minerals