Diabetes Visual Function Supplement Study (DiVFuSS)
January 20, 2015 updated by: ZeaVision, LLC
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
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98466
- Chous Eye Care Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan P. Chous, O.D., Chous Eye Care Associates
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
July 3, 2012
First Submitted That Met QC Criteria
July 17, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 22, 2015
Last Update Submitted That Met QC Criteria
January 20, 2015
Last Verified
January 1, 2015
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.