- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646047
Diabetes Visual Function Supplement Study (DiVFuSS)
Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98466
- Chous Eye Care Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diabetes mellitus diagnosed at least 5 years
- age greater than or equal to 18 years
- English speaker
Exclusion Criteria:
- proliferative diabetic retinopathy or severe non-proliferative retinopathy
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: supplement - no retinopathy
subjects receiving active supplement and with no retinopathy based on clinical examination
|
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 Comparator: placebo - no retinopathy
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
|
placebo capsules
Other Names:
|
Experimental: supplement - retinopathy
patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
|
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 Comparator: placebo - retinopathy
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
|
placebo capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in visual function
Time Frame: At baseline and again at six months
|
Change in contrast sensitivity, color vision and macular perimetry thresholds
|
At baseline and again at six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in serum markers
Time Frame: At baseline and again at six months
|
Changes in glycosylated hemoglobin, serum lipids, serum vitamin D (all subjects) and the serum inflammatory cytokine, tumor necrosis factor-alpha (subjects with retinopathy)
|
At baseline and again at six months
|
Changes in retinal structure
Time Frame: At baseline and again at 6 months
|
Changes in optical coherence tomography and macular pigment optical density
|
At baseline and again at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan P. Chous, O.D., Chous Eye Care Associates
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20112190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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