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
Inclusion Criteria1
- - 45 year-old healthy males and females.
Exclusion Criteria1
- Subjects who smoke, are currently being treated with anti-folate drugs, are planning a pregnancy or are currently pregnant, are unable to participate in all phases of the trial, or are supplementing their diet with more than 50% of the recommended daily dietary allowance (RDA) of any nutrients identified for the study.
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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)
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ACTRN12607000651482