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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000651482

Enrollment

250

Registered

2007-12-20

Start date

2007-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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, ageing, nutrition practices.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

25 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

25 - 45 year-old healthy males and females.

Exclusion criteria

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.

Outcome results