NCT00000152

Brief Summary

To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1982

Completed
17.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 2001

First QC Date

September 23, 1999

Last Update Submit

June 23, 2005

Conditions

Macular Degeneration

Keywords

Age-Related Macular Degeneration

Interventions

AspirinDRUG
Beta-CaroteneDRUG

Eligibility Criteria

Age40 Years - 84 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
When the Physicians Health Study was established in the early 1980s by the NHLBI to collect data on a stable population at risk for heart attack, only male physicians were studied because males were thought to be at higher risk than females for ischemic heart problems. The study population consists of 22,071 male U.S. physicians who were aged 40 to 84 years in 1982. The subjects have no history of myocardial infarction, cancer, kidney disease, renal disease, or any other contraindication to the use of aspirin or beta-carotene, including regular use of corticosteroids.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Christen WG, Manson JE, Glynn RJ, Gaziano JM, Chew EY, Buring JE, Hennekens CH. Beta carotene supplementation and age-related maculopathy in a randomized trial of US physicians. Arch Ophthalmol. 2007 Mar;125(3):333-9. doi: 10.1001/archopht.125.3.333.

    PMID: 17353403DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Aspirinbeta Carotene

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

April 1, 1982

Last Updated

June 24, 2005

Record last verified: 2001-09