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AzTrials

HealthyPhase 3NCT00272428

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

A Phase 3 study testing ascorbic acid, vitamin E, beta carotene, selenium, zinc in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ascorbic acid, vitamin E, beta carotene, selenium, zinc
How many people
13,000 participants
Where
1 siteFrance
Study dates
Oct 1994to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • disease likely to hinder active participation or threatened 5-year survival

Trial locations and contacts

1 site in 1 country.

France1 site

  • U557 Inserm

    Paris, 75003

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
ascorbic acid, vitamin E, beta carotene, selenium, zinc
Keywords
Prevention trial, Antioxydant vitamins and minerals, Cancer, Ischemic disease, Mortality, Health related quality of life
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ascorbic acid, vitamin E, beta carotene, selenium, zincBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major fatal and non fatal ischemic cardiovascular events

  2. Cancer any kind except for basal cell skin carcinoma

Secondary outcomes (5)

  1. All cause mortality

  2. Health-related quality of life

  3. Intermediate criteria of clinical status

  4. Intermediate criteria of biological status

  5. Intermediate criteria of anthropometric status

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2006 (estimated)
  2. Study startOct 1994
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
13,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272428
Sponsor's protocol ID
94-706
Status last verified
Oct 2007
First submitted
3 Jan 2006
Last updated
17 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, Roussel AM, Favier A, Briancon S. The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals. Arch Intern Med. 2004 Nov 22;164(21):2335-42. doi: 10.1001/archinte.164.21.2335.

    PubMed 15557412

  • Andreeva VA, Peneau S, Julia C, Shivappa N, Hebert JR, Wirth MD, Touvier M, Hercberg S, Galan P, Kesse-Guyot E. The inflammatory potential of the diet is prospectively associated with subjective hearing loss. Eur J Nutr. 2021 Oct;60(7):3669-3678. doi: 10.1007/s00394-021-02531-1. Epub 2021 Mar 18.

    PubMed 33738534

  • Lecuyer L, Dalle C, Micheau P, Petera M, Centeno D, Lyan B, Lagree M, Galan P, Hercberg S, Rossary A, Demidem A, Vasson MP, Partula V, Deschasaux M, Srour B, Latino-Martel P, Druesne-Pecollo N, Kesse-Guyot E, Durand S, Pujos-Guillot E, Manach C, Touvier M. Untargeted plasma metabolomic profiles associated with overall diet in women from the SU.VI.MAX cohort. Eur J Nutr. 2020 Dec;59(8):3425-3439. doi: 10.1007/s00394-020-02177-5. Epub 2020 Jan 11.

    PubMed 31927670

  • Lecuyer L, Dalle C, Lyan B, Demidem A, Rossary A, Vasson MP, Petera M, Lagree M, Ferreira T, Centeno D, Galan P, Hercberg S, Deschasaux M, Partula V, Srour B, Latino-Martel P, Kesse-Guyot E, Druesne-Pecollo N, Durand S, Pujos-Guillot E, Touvier M. Plasma Metabolomic Signatures Associated with Long-term Breast Cancer Risk in the SU.VI.MAX Prospective Cohort. Cancer Epidemiol Biomarkers Prev. 2019 Aug;28(8):1300-1307. doi: 10.1158/1055-9965.EPI-19-0154. Epub 2019 Jun 4.

    PubMed 31164347

  • Assmann KE, Adjibade M, Hercberg S, Galan P, Kesse-Guyot E. Unsaturated Fatty Acid Intakes During Midlife Are Positively Associated with Later Cognitive Function in Older Adults with Modulating Effects of Antioxidant Supplementation. J Nutr. 2018 Dec 1;148(12):1938-1945. doi: 10.1093/jn/nxy206.

    PubMed 30517725

  • Wiernik E, Lemogne C, Fezeu L, Arnault N, Hercberg S, Kesse-Guyot E, Galan P. Association Between Alexithymia and Risk of Incident Cardiovascular Diseases in the SUpplementation en VItamines et Mineraux AntioXydants (SU.VI.MAX) Cohort. Psychosom Med. 2018 Jun;80(5):460-467. doi: 10.1097/PSY.0000000000000592.

    PubMed 29649036

  • Assmann KE, Adjibade M, Shivappa N, Hebert JR, Wirth MD, Touvier M, Akbaraly T, Hercberg S, Galan P, Julia C, Kesse-Guyot E. The Inflammatory Potential of the Diet at Midlife Is Associated with Later Healthy Aging in French Adults. J Nutr. 2018 Mar 1;148(3):437-444. doi: 10.1093/jn/nxx061.

    PubMed 29546305

  • Ruhunuhewa I, Adjibade M, Andreeva VA, Galan P, Hercberg S, Assmann KE, Kesse-Guyot E. Prospective association between body mass index at midlife and healthy aging among French adults. Obesity (Silver Spring). 2017 Jul;25(7):1254-1262. doi: 10.1002/oby.21853. Epub 2017 May 11.

    PubMed 28494135

  • Adjibade M, Andreeva VA, Lemogne C, Touvier M, Shivappa N, Hebert JR, Wirth MD, Hercberg S, Galan P, Julia C, Assmann KE, Kesse-Guyot E. The Inflammatory Potential of the Diet Is Associated with Depressive Symptoms in Different Subgroups of the General Population. J Nutr. 2017 May;147(5):879-887. doi: 10.3945/jn.116.245167. Epub 2017 Mar 29.

    PubMed 28356432

  • Walker V, Perret-Guillaume C, Kesse-Guyot E, Agrinier N, Hercberg S, Galan P, Assmann KE, Briancon S, Rotonda C. Effect of Multimorbidity on Health-Related Quality of Life in Adults Aged 55 Years or Older: Results from the SU.VI.MAX 2 Cohort. PLoS One. 2016 Dec 29;11(12):e0169282. doi: 10.1371/journal.pone.0169282. eCollection 2016.

    PubMed 28033414

  • Kesse-Guyot E, Assmann KE, Andreeva VA, Touvier M, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Hercberg S, Galan P, Julia C. Long-term association between the dietary inflammatory index and cognitive functioning: findings from the SU.VI.MAX study. Eur J Nutr. 2017 Jun;56(4):1647-1655. doi: 10.1007/s00394-016-1211-3. Epub 2016 Apr 7.

    PubMed 27055851

  • Adriouch S, Julia C, Kesse-Guyot E, Mejean C, Ducrot P, Peneau S, Donnenfeld M, Deschasaux M, Menai M, Hercberg S, Touvier M, Fezeu LK. Prospective association between a dietary quality index based on a nutrient profiling system and cardiovascular disease risk. Eur J Prev Cardiol. 2016 Oct;23(15):1669-76. doi: 10.1177/2047487316640659. Epub 2016 Mar 21.

    PubMed 27000099

  • Graffouillere L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. The Dietary Inflammatory Index Is Associated with Prostate Cancer Risk in French Middle-Aged Adults in a Prospective Study. J Nutr. 2016 Apr 1;146(4):785-791. doi: 10.3945/jn.115.225623. Epub 2016 Mar 9.

    PubMed 26962176

  • Graffouillere L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. Prospective association between the Dietary Inflammatory Index and mortality: modulation by antioxidant supplementation in the SU.VI.MAX randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):878-85. doi: 10.3945/ajcn.115.126243. Epub 2016 Feb 10.

    PubMed 26864363

  • Deschasaux M, Souberbielle JC, Latino-Martel P, Sutton A, Charnaux N, Druesne-Pecollo N, Galan P, Hercberg S, Le Clerc S, Kesse-Guyot E, Ezzedine K, Touvier M. Weight Status and Alcohol Intake Modify the Association between Vitamin D and Breast Cancer Risk. J Nutr. 2016 Mar;146(3):576-85. doi: 10.3945/jn.115.221481. Epub 2016 Jan 27.

    PubMed 26817718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ascorbic acid, vitamin E, beta carotene, selenium, zinc in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major fatal and non fatal ischemic cardiovascular events. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272428, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2009.

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