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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Dietary Supplement: Centrum
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Nutritional supplements