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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00309387
First received: March 29, 2006
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Cataract
Dietary Supplement: Centrum
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Showing Development or Progression of Nuclear Lens Opacities [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
    number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up

  • Number of Participants Showing Development or Progression of Cortical Lens Opacities [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
    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

  • Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities [ Time Frame: at yearly intervals from baseline for approximately ten years ] [ Designated as safety issue: No ]
    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

  • Number of Participants Undergoing Cataract Surgery [ Time Frame: at 6 month intervals from baseline for approximately 10 yrs ] [ Designated as safety issue: No ]
    number of participants undergoing cataract surgery in at least one eligible eye during follow-up

  • Number of Participants With a Decrease in Visual Acuity [ Time Frame: at 6 month intervals from baseline for approximately 10 yrs ] [ Designated as safety issue: No ]
    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


Enrollment: 1020
Study Start Date: May 1995
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Centrum
multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.
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).
Placebo Comparator: placebo
placebo pills. One tablet a day for the whole study duration.
Other: Placebo
placebo tablets manufactured to mimic Centrum tablets.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309387

Locations
Italy
Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma
Parma, Italy, 43100
Sponsors and Collaborators
Investigators
Study Chair: Giovanni Maraini, MD University of Parma
Principal Investigator: Robert D Sperduto, MD National Eye Institute (NEI)
  More Information

Publications:
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00309387     History of Changes
Other Study ID Numbers: NEI-110
Study First Received: March 29, 2006
Results First Received: March 28, 2012
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by National Eye Institute (NEI):
Cataract
Nutritional supplements

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 16, 2014