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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-05-31

Study Completion Date

2007-05-31

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.

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Centrum

multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.

Group Type EXPERIMENTAL

Centrum

Intervention Type DIETARY_SUPPLEMENT

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

placebo pills. One tablet a day for the whole study duration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo tablets manufactured to mimic Centrum tablets.

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo tablets manufactured to mimic Centrum tablets.

Intervention Type OTHER

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes