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CataractPhase 3CTNSNCT00309387

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

A Phase 3 study testing Centrum in people with Cataract, run by National Eye Institute (NEI) at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Centrum
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,020 participants
Where
1 siteItaly
Study dates
May 1995to May 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma

    Parma, 43100

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Cataract
Being tested
Centrum, Placebo
Keywords
Cataract, Nutritional supplements
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CentrumDietary 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).

  • PlaceboOther

    placebo tablets manufactured to mimic Centrum tablets.

Study groups in NCT00309387
Study groupRoleWhat they receive
CentrumExperimentalmultivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration.
Receives: Dietary Supplement: Centrum
placeboPlacebo comparatorplacebo pills. One tablet a day for the whole study duration.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at yearly intervals from baseline for approximately ten years

Secondary outcomes (5)

  1. 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

    Measured: at yearly intervals from baseline for approximately ten years

  2. 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

    Measured: at yearly intervals from baseline for approximately ten years

  3. 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

    Measured: at yearly intervals from baseline for approximately ten years

  4. Number of Participants Undergoing Cataract Surgery

    number of participants undergoing cataract surgery in at least one eligible eye during follow-up

    Measured: at 6 month intervals from baseline for approximately 10 yrs

  5. 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

    Measured: at 6 month intervals from baseline for approximately 10 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2006 (estimated)
  2. Study startMay 1995
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309387
Sponsor's protocol ID
NEI-110
Acronym
CTNS
Status last verified
Apr 2013
First submitted
29 Mar 2006
Last updated
6 May 2013
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14662284

  • 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.

    PubMed 16019690

  • 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.

    PubMed 18387406

  • 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.

    PubMed 19636163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Centrum in people with Cataract, run by National Eye Institute (NEI) at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309387, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.

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