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: December 16, 2013
Last verified: December 2013

August 10, 2012
December 16, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01664819 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Not Provided
Not Provided
 
Antioxidants for Prevention of Cataracts Follow-up Study
Antioxidants for Prevention of Cataracts Follow-up Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cataract
Dietary Supplement: Antioxidant
  • 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.
    Intervention: Dietary Supplement: Antioxidant
  • Placebo Comparator: Placebo
    Randomized to receive placebo three times per week for five years
Gritz DC, Srinivasan M, Smith SD, Kim U, Lietman TM, Wilkins JH, Priyadharshini B, John RK, Aravind S, Prajna NV, Duraisami Thulasiraj R, Whitcher JP. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. Br J Ophthalmol. 2006 Jul;90(7):847-51. Epub 2006 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
798
May 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • participation in previous cataract study

Exclusion Criteria:

  • refusal to participate
Both
50 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01664819
P0047247
No
University of California, San Francisco
University of California, San Francisco
Aravind Eye Hospitals, India
Principal Investigator: Jeremy D Keenan, MD, MPH University of California, San Francisco
Principal Investigator: Muthiah Srinivasan, MD Aravind Eye Hospitals
University of California, San Francisco
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP