Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc

Study type

Interventional

Funder types

Other

Identifiers

NCT00272428

94-706

Details and patient eligibility

About

It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.

Full description

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.

Sex

All

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

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