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NCT00345176 · ClinicalTrials.gov registry record · Phase 3
Age-Related Eye Disease Study 2 (AREDS2)
A Phase 3 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 3
- Development phase
- 4,203
- Enrollment target
NCT00345176 is a Phase 3 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 4,203 participants.
The verdict
NCT00345176, a Phase 3 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,203 participants
- Enrollment target
Study Summary
Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.
Interventions
- DIETARY_SUPPLEMENT Lutein/zeaxanthin
- DIETARY_SUPPLEMENT DHA/EPA
- DRUG Lutein/zeaxanthin and DHA/EPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,203 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00345176
The ClinicalTrials.gov registry entry for NCT00345176 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lutein/zeaxanthin is the first listed.
NCT00345176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00345176 about?
NCT00345176 is a clinical study titled "Age-Related Eye Disease Study 2 (AREDS2)". Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lut...
What is the current status of trial NCT00345176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,203 participants. The study started on 2006-09. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00345176?
The interventions under investigation include: Lutein/zeaxanthin (DIETARY_SUPPLEMENT), DHA/EPA (DIETARY_SUPPLEMENT), Lutein/zeaxanthin and DHA/EPA (DRUG).
Who is sponsoring clinical trial NCT00345176?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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