RecruitingPhase 2ACTRN12607000651482

Nutritional polypill trial in well subjects in order to assess genome damage

A polypill vs placebo trial to assess genome damage in well subjects


Sponsor

NHMRC

Enrollment

250 participants

Start Date

Oct 1, 2007

Study Type

Interventional

Conditions

Summary

This study investigates the potential benefit of supplementary vitamins and essential minerals in the prevention of breaks in cellular DNA, which are associated with cancer development.


Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking a combination of vitamins and essential minerals (like a nutritional supplement) can reduce damage to the DNA inside our cells. DNA damage in cells is linked to the development of cancer, and certain vitamins and minerals are thought to help repair and protect DNA. Participants will take a supplement tablet each day and researchers will measure DNA damage in blood cells before and after the treatment. You may be eligible if: - You are between 25 and 45 years of age - You are in good general health (male or female) You may NOT be eligible if: - You are a current smoker - You are currently taking anti-folate drugs (certain medications that interfere with folate metabolism) - You are planning a pregnancy or are currently pregnant - You are already taking vitamin or mineral supplements at more than 50% of the recommended daily intake - You are unable to participate in all phases of the trial Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: 2 small tablets + 1 capsule, taken simultaneously, daily, orally; Contents: vitamins (B12, E, A, B3) and essential nutrients (folate, calcium); Duration: 16 weeks; Exposure: lifestyle,

Intervention: 2 small tablets + 1 capsule, taken simultaneously, daily, orally; Contents: vitamins (B12, E, A, B3) and essential nutrients (folate, calcium); Duration: 16 weeks; Exposure: lifestyle, ageing, nutrition practices.


Locations(1)

Australia

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ACTRN12607000651482