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

NCT00309387 | Completed Phase 3 Results DMC

• 1 other identifier: NEI-110
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; Nutritional supplements

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of Participants Showing Development or Progression of Nuclear Lens Opacities

  at yearly intervals from baseline for approximately ten years

• Number of Participants Showing Development or Progression of Cortical Lens Opacities

  at yearly intervals from baseline for approximately ten years

• Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities

  at yearly intervals from baseline for approximately ten years

• Number of Participants Undergoing Cataract Surgery

  at 6 month intervals from baseline for approximately 10 yrs

• Number of Participants With a Decrease in Visual Acuity

  at 6 month intervals from baseline for approximately 10 yrs

Study Arms (2)

Centrum

EXPERIMENTAL

multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.

Dietary Supplement: Centrum

placebo

PLACEBO COMPARATOR

placebo pills. One tablet a day for the whole study duration.

Other: Placebo

Interventions

Centrum DIETARY_SUPPLEMENT

Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).

Centrum

Placebo OTHER

placebo tablets manufactured to mimic Centrum tablets.

placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma

Parma, 43100, Italy

Location

Related Publications (4)

• 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.

  PMID: 14662284 BACKGROUND

• 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.

  PMID: 16019690 RESULT

• 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.

  PMID: 18387406 RESULT

• 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.

  PMID: 19636163 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Giovanni Maraini, MD
• Organization: University of Parma

maraini@unipr.it

+39 0521 238527

Study Officials

• Giovanni Maraini, MD

  University of Parma

  STUDY CHAIR

• Robert D Sperduto, MD

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: March 31, 2006
• Study Start: May 1, 1995
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 6, 2013
• Results First Posted: April 24, 2012

Record last verified: 2013-04

Locations

IT (1)