Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2012-05-31
2014-09-30
Brief Summary
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The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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supplement - no retinopathy
subjects receiving active supplement and with no retinopathy based on clinical examination
multi-component nutritional supplement capsules
two capsules containing nutritional supplements per day for 6 months (vitamin C, mixed tocopherols/tocotrienols, vitamin D, fish oil, lutein, zeaxanthin, pine bark extract, benfotiamine, green tea extract, curcumin)
placebo - no retinopathy
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
multi-component dietary supplement
placebo capsules
supplement - retinopathy
patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
multi-component nutritional supplement capsules
two capsules containing nutritional supplements per day for 6 months (vitamin C, mixed tocopherols/tocotrienols, vitamin D, fish oil, lutein, zeaxanthin, pine bark extract, benfotiamine, green tea extract, curcumin)
placebo - retinopathy
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
multi-component dietary supplement
placebo capsules
Interventions
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multi-component nutritional supplement capsules
two capsules containing nutritional supplements per day for 6 months (vitamin C, mixed tocopherols/tocotrienols, vitamin D, fish oil, lutein, zeaxanthin, pine bark extract, benfotiamine, green tea extract, curcumin)
multi-component dietary supplement
placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age greater than or equal to 18 years
* English speaker
Exclusion Criteria
* clinically significant macular edema
* corrected visual acuity less than 20/30 in either eye
* diagnosis of other serious eye disease (glaucoma, age-related maculopathy)
* less than 18 years old
* non-English speaker
* no known allergy or sensitivity to any supplement ingredients
18 Years
ALL
No
Sponsors
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ZeaVision, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Alan P. Chous, O.D.
Role: PRINCIPAL_INVESTIGATOR
Chous Eye Care Associates
Locations
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Chous Eye Care Associates
Tacoma, Washington, United States
Countries
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References
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Robertson NU, Schoonees A, Brand A, Visser J. Pine bark (Pinus spp.) extract for treating chronic disorders. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD008294. doi: 10.1002/14651858.CD008294.pub5.
Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18.
Other Identifiers
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20112190
Identifier Type: -
Identifier Source: org_study_id
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