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

Cataract Clinical Trial

— CTNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309387
• Other study ID #: NEI-110
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: April 30, 2013
• Start date: May 1995
• Est. completion date: May 2007

Study information

• Verified date: April 2013
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
Italy	Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Clinical Trial of Nutritional Supplements and Age-Related Cataract Study Group, Maraini G, Williams SL, Sperduto RD, Ferris F, Milton RC, Clemons TE, Rosmini F, Ferrigno L. A randomized, double-masked, placebo-controlled clinical trial of multivitamin sup — View Citation

CTNS Study Group. The Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract (CTNS): design implications. CTNS report no. 1. Control Clin Trials. 2003 Dec;24(6):815-29. — View Citation

Ferrigno L, Aldigeri R, Rosmini F, Sperduto RD, Maraini G; Italian-American Cataract Study Group. Associations between plasma levels of vitamins and cataract in the Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract (CTNS) — View Citation

Maraini G, Williams SL, Sperduto RD, Ferris FL, Milton RC, Clemons TE, Rosmini F, Ferrigno L. Effects of multivitamin/mineral supplementation on plasma levels of nutrients. Report No. 4 of the Italian-American clinical trial of nutritional supplements and — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up	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.	at yearly intervals from baseline for approximately ten years	No
Secondary	Number of Participants Showing Development or Progression of Nuclear Lens Opacities	number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up	at yearly intervals from baseline for approximately ten years	No
Secondary	Number of Participants Showing Development or Progression of Cortical Lens Opacities	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	at yearly intervals from baseline for approximately ten years	No
Secondary	Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities	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	at yearly intervals from baseline for approximately ten years	No
Secondary	Number of Participants Undergoing Cataract Surgery	number of participants undergoing cataract surgery in at least one eligible eye during follow-up	at 6 month intervals from baseline for approximately 10 yrs	No
Secondary	Number of Participants With a Decrease in Visual Acuity	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	at 6 month intervals from baseline for approximately 10 yrs	No