<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01664819</url>
  </required_header>
  <id_info>
    <org_study_id>P0047247</org_study_id>
    <nct_id>NCT01664819</nct_id>
  </id_info>
  <brief_title>Antioxidants for Prevention of Cataracts Follow-up Study</brief_title>
  <official_title>Antioxidants for Prevention of Cataracts Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aravind Eye Hospitals, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor&#xD;
      Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from&#xD;
      1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural&#xD;
      villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15&#xD;
      mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no&#xD;
      significant difference in cataract formation between the antioxidant group and placebo. In&#xD;
      this follow-up study, we will return to study villages to determine whether rates of cataract&#xD;
      surgery are different in the 2 groups.&#xD;
&#xD;
      1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts&#xD;
      Study: effects of antioxidant supplements on cataract progression in South India. The British&#xD;
      journal of ophthalmology 2006;90:847-51.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cataract surgery</measure>
    <time_frame>15 years post-intervention</time_frame>
    <description>Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for cataract surgery</measure>
    <time_frame>15 years post-intervention</time_frame>
    <description>Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>15 years post-intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">576</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Antioxidant supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Randomized to receive placebo three times per week for five years</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Antioxidant</intervention_name>
    <arm_group_label>Antioxidant supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participation in previous cataract study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy D Keenan, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muthiah Srinivasan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aravind Eye Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aravind Eye Hospitals</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>16556618</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>October 29, 2018</last_update_submitted>
  <last_update_submitted_qc>October 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antioxidants</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01664819
org study id: P0047247
nct id: NCT01664819
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Cataract surgery
time frame: 15 years post-intervention
description: Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model
measure: Risk factors for cataract surgery
time frame: 15 years post-intervention
description: Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model
measure: All-cause mortality
time frame: 15 years post-intervention
arm group label: Antioxidant supplementation
arm group type: Active Comparator
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 group label: Placebo
arm group type: Placebo Comparator
description: Randomized to receive placebo three times per week for five years
intervention type: Dietary Supplement
intervention name: Antioxidant
arm group label: Antioxidant supplementation
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jeremy D Keenan, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Muthiah Srinivasan, MD
role: Principal Investigator
affiliation: Aravind Eye Hospitals
facility: 
country: India
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.
PMID: 16556618
responsible party type: Sponsor
mesh term: Cataract
mesh term: Antioxidants