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
  Purpose

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
Healthy
Behavioral: ascorbic acid, vitamin E, beta carotene, selenium, zinc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Major fatal and non fatal ischemic cardiovascular events
  • Cancer any kind except for basal cell skin carcinoma

Secondary Outcome Measures:
  • All cause mortality
  • Health-related quality of life
  • Intermediate criteria of clinical status
  • Intermediate criteria of biological status
  • Intermediate criteria of anthropometric status

Estimated Enrollment: 13000
Study Start Date: October 1994
Study Completion Date: September 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00272428

Locations
France
U557 Inserm
Paris, France, 75003
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
French private agencies
Investigators
Principal Investigator: Serge Hercberg, MD, PhD U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00272428     History of Changes
Other Study ID Numbers: 94-706
Study First Received: January 3, 2006
Last Updated: December 16, 2009
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Prevention trial
Antioxydant vitamins and minerals
Cancer
Ischemic disease
Mortality
Health related quality of life

Additional relevant MeSH terms:
Antioxidants
Ascorbic Acid
Vitamin E
Vitamins
Beta Carotene
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014