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

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ClinicalTrials.gov Identifier: NCT00309387
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : April 24, 2012
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
National Eye Institute (NEI)

Tracking Information
First Submitted Date  ICMJE March 29, 2006
First Posted Date  ICMJE March 31, 2006
Results First Submitted Date  ICMJE March 28, 2012
Results First Posted Date  ICMJE April 24, 2012
Last Update Posted Date May 6, 2013
Study Start Date  ICMJE May 1995
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2006)
Photographic evaluation of incidence and progression of "any" lens event and of specific cataract types.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
  • Number of Participants Showing Development or Progression of Nuclear Lens Opacities [ Time Frame: at yearly intervals from baseline for approximately ten years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2006)
Incidence and progression rates and risk factors for the disease.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Official Title  ICMJE Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Centrum
    multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.
    Intervention: Dietary Supplement: Centrum
  • Placebo Comparator: placebo
    placebo pills. One tablet a day for the whole study duration.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2006)
1020
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00309387
Other Study ID Numbers  ICMJE NEI-110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Eye Institute (NEI)
Study Sponsor  ICMJE National Eye Institute (NEI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Giovanni Maraini, MD University of Parma
Principal Investigator: Robert D Sperduto, MD National Eye Institute (NEI)
PRS Account National Eye Institute (NEI)
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP