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Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00342992
Enrollment
29133
Registered
2006-06-21
Start date
1995-03-03
Completion date
2020-09-04
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Diabetes Mellitus, Heart Disease, Stroke

Keywords

Vitamin E, Micronutrients, Genetics, Smoking, Biomarkers

Brief summary

The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry. The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).

Detailed description

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.

Interventions

None listed

Sponsors

Finnish Institute for Health and Welfare
CollaboratorOTHER_GOV
National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

Exclusion criteria

* Females * Proven malignancy (except nonmelanoma skin cancer or cancer in situ) * Severe angina pectoris * Chronic renal insufficiency * Cirrhosis of the liver * Chronic alcoholism * Anticoagulant therapy * Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day

Design outcomes

Primary

MeasureTime frameDescription
CancerAnnuallyAnnual linkage with Finnish Cancer Registry

Secondary

MeasureTime frame
Causes of mortalityAnually

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026