Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) (CTNS)

April 30, 2013 updated by: National Eye Institute (NEI)
The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in preventing age-related cataract or delaying its progression in participants with early or no cataract at baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite dramatic increase in the rates of cataract surgery during the last decades, age-related cataract is still responsible for about 50% of cases of severe visual impairment in developing countries, and for high and growing health care costs in western countries. CTNS was designed to complement the U.S. Age-Related Eye Disease Study (AREDS) by evaluating a much broader spectrum of nutrients at RDA dosages. Whereas about 60% of the AREDS control group was taking RDA dose multivitamin supplements, none of the participants in CTNS had taken any type of nutritional supplement for at least one year before the qualification visit. Therefore, the CTNS will be able to evaluate the effect of RDA doses versus no supplementation at all. CTNS and AREDS will use similar procedures, including those for grading the presence and severity of lens changes.

CTNS is a randomized,parallel group, placebo controlled, double blinded, single center, intervention trial.

Primary Outcomes: photographic evaluation of a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract surgery.

Secondary Outcomes: increase in type-specific opacity grade, cataract surgery, and visual acuity loss from baseline > or = 15 letters.

Patients will be followed for a maximum of 10 years.

Study Type

Interventional

Enrollment (Actual)

1020

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and photographic diagnosis of early or no age-related cataract
  • Participants with early cataract must have at least one eligible eye with VA score 20/32 or better
  • Participants with no cataract must have VA score 20/32 or better in both eyes.

Exclusion Criteria:

  • Advanced cataract
  • Bilateral aphakia or pseudophakia
  • Any ocular disease or condition that might complicate the future evaluation of cataract
  • Regular use of nutritional supplements
  • Failure to take at least 75% of run-in medication
  • Cancer with evidence of recurrence in the past 5 years
  • Major cerebral or cardiovascular events in past 12 months
  • Current participation to other clinical trials
  • Any condition likely to prevent adherence to CTNS follow-up schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Centrum
multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.
Dietary supplement: Centrum
Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).
Placebo Comparator: placebo
placebo pills. One tablet a day for the whole study duration.
Other: Placebo
placebo tablets manufactured to mimic Centrum tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
Time Frame: at yearly intervals from baseline for approximately ten years
number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.
at yearly intervals from baseline for approximately ten years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Showing Development or Progression of Nuclear Lens Opacities
Time Frame: at yearly intervals from baseline for approximately ten years
number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up
at yearly intervals from baseline for approximately ten years
Number of Participants Showing Development or Progression of Cortical Lens Opacities
Time Frame: at yearly intervals from baseline for approximately ten years
Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up
at yearly intervals from baseline for approximately ten years
Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities
Time Frame: at yearly intervals from baseline for approximately ten years
Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up
at yearly intervals from baseline for approximately ten years
Number of Participants Undergoing Cataract Surgery
Time Frame: at 6 month intervals from baseline for approximately 10 yrs
number of participants undergoing cataract surgery in at least one eligible eye during follow-up
at 6 month intervals from baseline for approximately 10 yrs
Number of Participants With a Decrease in Visual Acuity
Time Frame: at 6 month intervals from baseline for approximately 10 yrs
Number of participants with a decrease in best corrected visual acuity score from baseline of > 15 letters in at least one eligible eye during follow-up
at 6 month intervals from baseline for approximately 10 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Investigators

  • Study Chair: Giovanni Maraini, MD, University of Parma
  • Principal Investigator: Robert D Sperduto, MD, National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1995

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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