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Antioxidants for Prevention of Cataracts Follow-up Study

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ClinicalTrials.gov Identifier: NCT01664819
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2012
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
Aravind Eye Hospitals, India
Information provided by (Responsible Party):
University of California, San Francisco

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
Cataract Dietary Supplement: Antioxidant Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 798 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 : July 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cataract surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 15 years post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participation in previous cataract study

Exclusion Criteria:

  • refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01664819     History of Changes
Other Study ID Numbers: P0047247
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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