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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major fatal and non fatal ischemic cardiovascular events |  |  | 
| Cancer any kind except for basal cell skin carcinoma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  |  | 
| Health-related quality of life |  |  | 
| Intermediate criteria of clinical status |  |  | 
| Intermediate criteria of biological status |  |  | 
| Intermediate criteria of anthropometric status |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Prevention trial, Antioxydant vitamins and minerals, Ischemic disease, Mortality, Health related quality of life