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The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

Phase 3
35 Years
60 Years
Not Enrolling

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Trial Information

The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

From experimental studies it is known that free radicals may induce numerous pathological
processes, and it has been suggested that, because of their antioxidant capacity, nutrients
such as beta-carotene, vitamin C, vitamin E, selenium and zinc may prevent such harmful
effects. Epidemiological data from cross-sectional, case-control, and prospective studies
have indeed shown a strong relationship between the intake of antioxidant vitamins and
minerals, or foods rich in these nutrients, and the risk of cancer and ischaemic
cardiovascular diseases (CVD). However, randomised placebo-controlled primary prevention
trials, in which antioxidant micronutrients alone or in pairs were given at high doses over
long periods, have not been able to prove this potential beneficial effect, and two of these
even suggested harmful effects. The seemingly contradictory results between the
observational studies and these randomised trials can be explained by the fact that the
doses used in clinical trials were much higher than the highest levels reachable by usual
dietary intake which have been found to be associated in observational studies with the
lowest risk of cancer and CVD. In fact, the only trial which did observe a beneficial effect
on total mortality and cancer incidence used nutritional doses of a combination of several
vitamins and minerals and was performed on Chinese population with very low baseline
micronutrient status, due to poor life conditions in this region (9).

The objective of the "SUpplementation en VItamines et Minéraux AntioXydants" (SU.VI.MAX)
study, was to test in a randomised, placebo-controlled trial, if an adequate and well
balanced intake of antioxidant nutrients reduces the incidence of cancers and ischaemic
cardiovascular diseases in a middle-age general population.

Inclusion Criteria:

- women aged 35-60 years, men aged 45-60 years

- acceptance of the possibility to be given a placebo and acceptance of the constraints
of participation

- lack of previous regular supplementation with any of the vitamins or minerals in the
supplement provided

- absence of extreme beliefs or behavior regarding diet

Exclusion Criteria:

- disease likely to hinder active participation or threatened 5-year survival

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Major fatal and non fatal ischemic cardiovascular events

Principal Investigator

Serge Hercberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM


France: National Consultative Ethics Committee for Health and Life Sciences

Study ID:




Start Date:

October 1994

Completion Date:

September 2005

Related Keywords:

  • Healthy
  • Prevention trial
  • Antioxydant vitamins and minerals
  • Cancer
  • Ischemic disease
  • Mortality
  • Health related quality of life