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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centrum | Experimental | multivitamin-mineral supplement. RDA dosage. 1 tablet a day for the whole study duration. |
|
| placebo | Placebo Comparator | placebo pills. One tablet a day for the whole study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants Showing Development or Progression of Cortical Lens Opacities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Maraini, MD | University of Parma | Study Chair |
| Robert D Sperduto, MD | National Eye Institute (NEI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt. Scienze Otorino-Odonto Oftalmologiche, University of Parma | Parma | 43100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14662284 | Background | 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. | |
| 16019690 | Result | 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. |
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Potential participants had to complete a 1-month placebo run-in period (use of > 75% of the run-in tablets) before randomization
1020 participants were enrolled from January 8, 1996 through April 10, 1998 at the Institute of Ophthalmology of the University of Parma, Parma, Italy
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat analysis | Posted | Number | participants | at yearly intervals from baseline for approximately ten years |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Maraini, MD | University of Parma | +39 0521 238527 | maraini@unipr.it |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Placebo | Other | placebo tablets manufactured to mimic Centrum tablets. |
|
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 |
| 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 |
| 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 |
| 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 |
| 18387406 | 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. |
| 19636163 | 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. |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo |
|
|
|
| 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 | intention to treat | Posted | Number | participants | at yearly intervals from baseline for approximately ten years |
|
|
|
| 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 | intention to treat | Posted | Number | participants | at yearly intervals from baseline for approximately ten years |
|
|
|
| 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 | intention to treat | Posted | Number | participants | at yearly intervals from baseline for approximately ten years |
|
|
|
| Secondary | Number of Participants Undergoing Cataract Surgery | number of participants undergoing cataract surgery in at least one eligible eye during follow-up | intention to treat | Posted | Number | participants | at 6 month intervals from baseline for approximately 10 yrs |
|
|
|
| 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 | intention to treat | Posted | Number | participants | at 6 month intervals from baseline for approximately 10 yrs |
|
|
|
| 363 |
| 510 |
| 39 |
| 510 |
| EG001 | Placebo | 397 | 510 | 38 | 510 |
| hospitalization | General disorders | Systematic Assessment |
|
| increased weight | General disorders | Systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment |
|
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