Trials / Completed
CompletedNCT01646047
Diabetes Visual Function Supplement Study
Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- ZeaVision, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo. The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement
Detailed description
Adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin D status. A multi-component dietary supplement containing ingredients currently available over the counter in the US will be taken for six months and repeat measurements of the above parameters obtained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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) |
| DIETARY_SUPPLEMENT | multi-component dietary supplement | placebo capsules |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2012-07-20
- Last updated
- 2015-01-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01646047. Inclusion in this directory is not an endorsement.