Clinical trial NCT00309387: Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Official title: Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract
Nutritional supplements
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 2006-03-31
Enrollment: 1020
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
timeFrame: at yearly intervals from baseline for approximately ten years
Secondary outcomes:
measure: Number of Participants Showing Development or Progression of Nuclear Lens Opacities
timeFrame: at yearly intervals from baseline for approximately ten years
measure: Number of Participants Showing Development or Progression of Cortical Lens Opacities
timeFrame: at yearly intervals from baseline for approximately ten years
measure: Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities
timeFrame: at yearly intervals from baseline for approximately ten years
measure: Number of Participants Undergoing Cataract Surgery
timeFrame: at 6 month intervals from baseline for approximately 10 yrs
measure: Number of Participants With a Decrease in Visual Acuity
timeFrame: at 6 month intervals from baseline for approximately 10 yrs
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma
Study officials:
affiliation: University of Parma
name: Giovanni Maraini, MD
role: STUDY_CHAIR
affiliation: National Eye Institute (NEI)
name: Robert D Sperduto, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0197-2456(03)00095-3.
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): CTNS Report #2. Ophthalmic Epidemiol. 2005 Apr;12(2):71-80. doi: 10.1080/09286580590932815.
citation: 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 supplementation for age-related lens opacities. Clinical trial of nutritional supplements and age-related cataract report no. 3. Ophthalmology. 2008 Apr;115(4):599-607.e1. doi: 10.1016/j.ophtha.2008.01.005.
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 age-related cataract. Ann Ist Super Sanita. 2009;45(2):119-27.