NCT00309387

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,020 (actual)
• Sponsor: National Eye Institute (NEI) · NIH
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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

• Cataract

Interventions

Type	Name	Description
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).
OTHER	Placebo	placebo tablets manufactured to mimic Centrum tablets.

Timeline

• Start date: 1995-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-03-31
• Last updated: 2013-05-06
• Results posted: 2012-04-24

Locations

1 site across 1 country: Italy