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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Other: Placebo; Dietary Supplement: Centrum

Study type: Interventional

Funder types: NIH

Identifiers

NCT00309387

NEI-110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,020 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,020 participants in 2 patient groups, including a placebo group

Centrum

Experimental group

Description:

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

Treatment:

Dietary Supplement: Centrum

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo