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Antioxidants for Prevention of Cataracts Follow-up Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01664819
Collaborator
Aravind Eye Hospitals, India (Other)
576
Enrollment
1
Location
2
Arms
12
Duration (Months)
48
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Dietary Supplement: Antioxidant
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
576 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Antioxidants for Prevention of Cataracts Follow-up Study
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

  1. Cataract surgery [15 years post-intervention]

    Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model

Secondary Outcome Measures

  1. Risk factors for cataract surgery [15 years post-intervention]

    Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model

  2. All-cause mortality [15 years post-intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • participation in previous cataract study
Exclusion Criteria:
  • refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01664819
Other Study ID Numbers:
  • P0047247
First Posted:
Aug 14, 2012
Last Update Posted:
Oct 30, 2018
Last Verified:
Oct 1, 2018
Additional relevant MeSH terms:
Cataract
Antioxidants

Study Results

No Results Posted as of Oct 30, 2018