Trial Outcomes & Findings for Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) (NCT NCT00309387)
NCT ID: NCT00309387
Last Updated: 2013-05-06
Results Overview
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.
COMPLETED
PHASE3
1020 participants
at yearly intervals from baseline for approximately ten years
2013-05-06
Participant Flow
1020 participants were enrolled from January 8, 1996 through April 10, 1998 at the Institute of Ophthalmology of the University of Parma, Parma, Italy
Potential participants had to complete a 1-month placebo run-in period (use of \> 75% of the run-in tablets) before randomization
Participant milestones
| Measure |
Treatment
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
510
|
510
|
|
Overall Study
COMPLETED
|
368
|
351
|
|
Overall Study
NOT COMPLETED
|
142
|
159
|
Reasons for withdrawal
| Measure |
Treatment
|
Placebo
|
|---|---|---|
|
Overall Study
Death
|
72
|
73
|
|
Overall Study
Lost to Follow-up
|
70
|
86
|
Baseline Characteristics
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Baseline characteristics by cohort
| Measure |
Treatment
n=510 Participants
|
Placebo
n=510 Participants
|
Total
n=1020 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
371 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
741 Participants
n=5 Participants
|
|
Age Continuous
|
67.7 years
STANDARD_DEVIATION 4.82 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 4.97 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
459 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
277 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
561 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
510 participants
n=5 Participants
|
510 participants
n=7 Participants
|
1020 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at yearly intervals from baseline for approximately ten yearsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
|
227 participants
|
255 participants
|
SECONDARY outcome
Timeframe: at yearly intervals from baseline for approximately ten yearsPopulation: intention to treat
number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants Showing Development or Progression of Nuclear Lens Opacities
|
84 participants
|
118 participants
|
SECONDARY outcome
Timeframe: at yearly intervals from baseline for approximately ten yearsPopulation: intention to treat
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
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants Showing Development or Progression of Cortical Lens Opacities
|
96 participants
|
118 participants
|
SECONDARY outcome
Timeframe: at yearly intervals from baseline for approximately ten yearsPopulation: intention to treat
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
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities
|
74 participants
|
37 participants
|
SECONDARY outcome
Timeframe: at 6 month intervals from baseline for approximately 10 yrsPopulation: intention to treat
number of participants undergoing cataract surgery in at least one eligible eye during follow-up
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants Undergoing Cataract Surgery
|
88 participants
|
90 participants
|
SECONDARY outcome
Timeframe: at 6 month intervals from baseline for approximately 10 yrsPopulation: intention to treat
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
Outcome measures
| Measure |
Treatment
n=510 Participants
Centrum
|
Placebo
n=510 Participants
Placebo
|
|---|---|---|
|
Number of Participants With a Decrease in Visual Acuity
|
144 participants
|
139 participants
|
Adverse Events
Treatment
Placebo
Serious adverse events
| Measure |
Treatment
n=510 participants at risk
|
Placebo
n=510 participants at risk
|
|---|---|---|
|
General disorders
death
|
15.1%
77/510 • 6 months
|
15.9%
81/510 • 6 months
|
|
General disorders
hospitalization
|
56.1%
286/510 • Number of events 573 • 6 months
|
62.0%
316/510 • Number of events 604 • 6 months
|
Other adverse events
| Measure |
Treatment
n=510 participants at risk
|
Placebo
n=510 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
upset stomach
|
3.3%
17/510 • Number of events 17 • 6 months
|
3.7%
19/510 • Number of events 19 • 6 months
|
|
General disorders
increased weight
|
0.59%
3/510 • Number of events 3 • 6 months
|
0.59%
3/510 • Number of events 3 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.98%
5/510 • Number of events 5 • 6 months
|
0.78%
4/510 • Number of events 4 • 6 months
|
|
General disorders
other
|
2.7%
14/510 • Number of events 14 • 6 months
|
2.4%
12/510 • Number of events 12 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place