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

This study has been completed.
Sponsor:
Collaborator:
French private agencies
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00272428
First received: January 3, 2006
Last updated: December 16, 2009
Last verified: October 2007

January 3, 2006
December 16, 2009
October 1994
Not Provided
  • Major fatal and non fatal ischemic cardiovascular events
  • Cancer any kind except for basal cell skin carcinoma
Same as current
Complete list of historical versions of study NCT00272428 on ClinicalTrials.gov Archive Site
  • All cause mortality
  • Health-related quality of life
  • Intermediate criteria of clinical status
  • Intermediate criteria of biological status
  • Intermediate criteria of anthropometric status
Same as current
Not Provided
Not Provided
 
Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Healthy
Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13000
September 2005
Not Provided

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
Both
35 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00272428
94-706
Yes
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
French private agencies
Principal Investigator: Serge Hercberg, MD, PhD U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM
Institut National de la Santé Et de la Recherche Médicale, France
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP