Antioxidants for Prevention of Cataracts Follow-up Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Aravind Eye Hospitals, India
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01664819
First received: August 10, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from 1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. In this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups.

1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. The British journal of ophthalmology 2006;90:847-51.


Condition Intervention
Cataract
Dietary Supplement: Antioxidant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Antioxidants for Prevention of Cataracts Follow-up Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Cataract surgery [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]
    Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model


Secondary Outcome Measures:
  • Risk factors for cataract surgery [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]
    Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model

  • All-cause mortality [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 798
Study Start Date: July 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antioxidant supplementation
Randomized to receive antioxidant supplementation (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) three times per week for five years.
Dietary Supplement: Antioxidant
Placebo Comparator: Placebo
Randomized to receive placebo three times per week for five years

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participation in previous cataract study

Exclusion Criteria:

  • refusal to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664819

Locations
India
Aravind Eye Hospitals
Madurai, Tamil Nadu, India
Sponsors and Collaborators
University of California, San Francisco
Aravind Eye Hospitals, India
Investigators
Principal Investigator: Jeremy D Keenan, MD, MPH University of California, San Francisco
Principal Investigator: Muthiah Srinivasan, MD Aravind Eye Hospitals
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01664819     History of Changes
Other Study ID Numbers: P0047247
Study First Received: August 10, 2012
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014