Back to resultsAntioxidants for Prevention of Cataracts Follow-up Study
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Antioxidant
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- participation in previous cataract study
Exclusion Criteria:
- refusal to participate
Sites / Locations
- Aravind Eye Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antioxidant supplementation
Placebo
Arm Description
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.
Randomized to receive placebo three times per week for five years
Outcomes
Primary Outcome Measures
Cataract surgery
Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model
Secondary Outcome Measures
Risk factors for cataract surgery
Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model
All-cause mortality
Full Information
NCT ID
NCT01664819
First Posted
August 10, 2012
Last Updated
October 29, 2018
Sponsor
University of California, San Francisco
Collaborators
Aravind Eye Hospitals, India
1. Study Identification
Unique Protocol Identification Number
NCT01664819
Brief Title
Antioxidants for Prevention of Cataracts Follow-up Study
Official Title
Antioxidants for Prevention of Cataracts Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Aravind Eye Hospitals, India
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
576 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant supplementation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized to receive placebo three times per week for five years
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cataract surgery
Description
Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model
Time Frame
15 years post-intervention
Secondary Outcome Measure Information:
Title
Risk factors for cataract surgery
Description
Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model
Time Frame
15 years post-intervention
Title
All-cause mortality
Time Frame
15 years post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participation in previous cataract study
Exclusion Criteria:
refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muthiah Srinivasan, MD
Organizational Affiliation
Aravind Eye Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospitals
City
Madurai
State/Province
Tamil Nadu
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
16556618
Citation
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. doi: 10.1136/bjo.2005.088104. Epub 2006 Mar 23.
Results Reference
background
PubMed Identifier
35817091
Citation
Nesemann JM, Srinivasan M, Ravindran RD, Edwards T, O'Brien KS, Kim UR, Wilkins JH, Whitcher JP, Lietman TM, Gritz DC, Keenan JD. Relationship Between Cooking Fuel and Lens Opacities in South India: A 15-Year Prospective Cohort Study. Am J Ophthalmol. 2022 Nov;243:66-76. doi: 10.1016/j.ajo.2022.06.021. Epub 2022 Jul 9.
Results Reference
derived
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Antioxidants for Prevention of Cataracts Follow-up Study
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