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Sponsors and Collaborators: |
Institut National de la Santé Et de la Recherche Médicale, France French private agencies |
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Information provided by: | Institut National de la Santé Et de la Recherche Médicale, France |
ClinicalTrials.gov Identifier: | NCT00272428 |
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.
Condition | Intervention | Phase |
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Healthy |
Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The SU.VI.MAX Study. A Randomized, Placebo-Controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals. |
Estimated Enrollment: | 13000 |
Study Start Date: | October 1994 |
Study Completion Date: | September 2005 |
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.
Ages Eligible for Study: | 35 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
U557 Inserm | |
Paris, France, 75003 |
Principal Investigator: | Serge Hercberg, MD, PhD | U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM |
Study ID Numbers: | 94-706 |
Study First Received: | January 3, 2006 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00272428 History of Changes |
Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences |
Prevention trial Antioxydant vitamins and minerals Cancer |
Ischemic disease Mortality Health related quality of life |
Tocopherol acetate Beta Carotene Antioxidants Tocopherol Quality of Life Trace Elements Ischemia Healthy Alpha-Tocopherol Vitamin C |
Tocopherols Selenium Vitamin E Tocotrienol Vitamins Zinc Tocotrienols Micronutrients Carotenoids Ascorbic Acid |
Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions Ascorbic Acid |