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Age-Related Eye Disease Study 2 (AREDS2) (AREDS2)

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ClinicalTrials.gov Identifier: NCT00345176
Recruitment Status : Completed
First Posted : June 27, 2006
Results First Posted : December 24, 2013
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
National Eye Institute (NEI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Age-related Macular Degeneration
Cataract
Interventions: Dietary Supplement: Lutein/zeaxanthin
Dietary Supplement: DHA/EPA
Drug: Lutein/zeaxanthin and DHA/EPA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 2006 and September 2008 a total of 4,203 participants aged 50 - 85 years were randomized at 82 clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, participants had to complete the Qualification phase. They could only be randomized if they took at least 75% of the run-in medication.

Reporting Groups
  Description
Placebo/Control Considered control because all participants received the AREDS formulation
Lutein/Zeaxanthin lutein (10mg)/zeaxanthin (2 mg)
DHA/EPA DHA (350 mg)/EPA (650 mg)
Lutein/Zeaxanthin + DHA/EPA lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)

Participant Flow:   Overall Study
    Placebo/Control   Lutein/Zeaxanthin   DHA/EPA   Lutein/Zeaxanthin + DHA/EPA
STARTED   1012   1044   1068   1079 
COMPLETED   1007   1038   1062   1069 
NOT COMPLETED   5   6   6   10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo/Control Considered control because all participants received the AREDS formulation
Lutein/Zeaxanthin lutein (10mg)/zeaxanthin (2 mg)
DHA/EPA DHA (350 mg)/EPA (650 mg)
Lutein/Zeaxanthin + DHA/EPA lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
Total Total of all reporting groups

Baseline Measures
   Placebo/Control   Lutein/Zeaxanthin   DHA/EPA   Lutein/Zeaxanthin + DHA/EPA   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 1012   1044   1068   1079   4203 
Age 
[Units: Participants]
Median (Inter-Quartile Range) 		 74 
 (68 to 79)  		 74 
 (68 to 79)  		 74 
 (68 to 79)  		 75 
 (68 to 79)  		 74 
 (68 to 79) 
Gender 
[Units: Participants]
 		         
Female   548   596   603   641   2388 
Male   464   448   465   438   1815 


  Outcome Measures

1.  Primary:   Development of Advanced AMD in People at Moderate to High Risk for Progression.   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 1

2.  Secondary:   Progression to Moderate Vision Loss   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 2

3.  Secondary:   Adverse Events   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 3

4.  Secondary:   Progression to Cataract Surgery   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Incident Cardiovascular Disease   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Cognition as Measured by a Telephone Battery   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Prevalence of Peripheral Changes as Measured Using OPTOS Imaging   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Genetics for the Association of AMD and Cataract   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Genetics for the Progression of AMD and Cataract   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Traci Clemons, PhD
Organization: The EMMES Corporation
phone: 301-251-1161 ext 212
e-mail: tclemons@emmes.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00345176     History of Changes
Obsolete Identifiers: NCT00409513
Other Study ID Numbers: NEI-120
N01-EY-5-0007 ( Other Grant/Funding Number: NIH )
HHS-N-260-2005-00007-C ( Other Grant/Funding Number: HHS )
CC-070025 ( Other Identifier: NIH Clinical Center )
07-EI-0025 ( Other Identifier: National Eye Institute )
First Submitted: June 14, 2006
First Posted: June 27, 2006
Results First Submitted: November 1, 2013
Results First Posted: December 24, 2013
Last Update Posted: May 5, 2015