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

NCT00309387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2013-05-06

Study results available
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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.

Conditions

  • Cataract

Interventions

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Giovanni Maraini, MD · University of Parma

  • Robert D Sperduto, MD · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1995-05-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00309387 on ClinicalTrials.gov