Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
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|ClinicalTrials.gov Identifier: NCT00272428|
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : December 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||13000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.|
|Study Start Date :||October 1994|
|Actual Study Completion Date :||September 2005|
- Major fatal and non fatal ischemic cardiovascular events
- Cancer any kind except for basal cell skin carcinoma
- All cause mortality
- Health-related quality of life
- Intermediate criteria of clinical status
- Intermediate criteria of biological status
- Intermediate criteria of anthropometric status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272428
|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|