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

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ClinicalTrials.gov Identifier: NCT00309387
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : April 24, 2012
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
National Eye Institute (NEI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Dietary Supplement: Centrum
Other: Placebo
Enrollment 1020
Recruitment Details 1020 participants were enrolled from January 8, 1996 through April 10, 1998 at the Institute of Ophthalmology of the University of Parma, Parma, Italy
Pre-assignment Details Potential participants had to complete a 1-month placebo run-in period (use of > 75% of the run-in tablets) before randomization
Arm/Group Title Treatment Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 510 510
Completed 368 351
Not Completed 142 159
Reason Not Completed
Death             72             73
Lost to Follow-up             70             86
Arm/Group Title Treatment Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 510 510 1020
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 510 participants 1020 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
139
  27.3%
140
  27.5%
279
  27.4%
>=65 years
371
  72.7%
370
  72.5%
741
  72.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 510 participants 510 participants 1020 participants
67.7  (4.82) 67.7  (4.97) 67.7  (4.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 510 participants 1020 participants
Female
233
  45.7%
226
  44.3%
459
  45.0%
Male
277
  54.3%
284
  55.7%
561
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 510 participants 510 participants 1020 participants
510 510 1020
1.Primary Outcome
Title Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
Hide Description 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.
Time Frame at yearly intervals from baseline for approximately ten years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
Placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
227 255
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.68 to 0.98
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Showing Development or Progression of Nuclear Lens Opacities
Hide Description number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up
Time Frame at yearly intervals from baseline for approximately ten years
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
Placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
84 118
3.Secondary Outcome
Title Number of Participants Showing Development or Progression of Cortical Lens Opacities
Hide Description 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
Time Frame at yearly intervals from baseline for approximately ten years
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
96 118
4.Secondary Outcome
Title Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities
Hide Description 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
Time Frame at yearly intervals from baseline for approximately ten years
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
Placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
74 37
5.Secondary Outcome
Title Number of Participants Undergoing Cataract Surgery
Hide Description number of participants undergoing cataract surgery in at least one eligible eye during follow-up
Time Frame at 6 month intervals from baseline for approximately 10 yrs
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
Placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
88 90
6.Secondary Outcome
Title Number of Participants With a Decrease in Visual Acuity
Hide Description 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
Time Frame at 6 month intervals from baseline for approximately 10 yrs
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Centrum
Placebo
Overall Number of Participants Analyzed 510 510
Measure Type: Number
Unit of Measure: participants
144 139
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   363/510 (71.18%)      397/510 (77.84%)    
General disorders     
death   77/510 (15.10%)  81/510 (15.88%) 
hospitalization   286/510 (56.08%)  573 316/510 (61.96%)  604
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/510 (7.65%)      38/510 (7.45%)    
Gastrointestinal disorders     
upset stomach   17/510 (3.33%)  17 19/510 (3.73%)  19
General disorders     
increased weight   3/510 (0.59%)  3 3/510 (0.59%)  3
other   14/510 (2.75%)  14 12/510 (2.35%)  12
Skin and subcutaneous tissue disorders     
skin rash   5/510 (0.98%)  5 4/510 (0.78%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Giovanni Maraini, MD
Organization: University of Parma
Phone: +39 0521 238527
EMail: maraini@unipr.it
Layout table for additonal information
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00309387    
Other Study ID Numbers: NEI-110
First Submitted: March 29, 2006
First Posted: March 31, 2006
Results First Submitted: March 28, 2012
Results First Posted: April 24, 2012
Last Update Posted: May 6, 2013