NCT01646047|CompletedDMC
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
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DiVFuSS
Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
Sponsor study identifier
interventional
70
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 3, 2012
Actual (reported)July 20, 2012
Actual (reported)August 2014
Actual (reported)September 2014
Actual (reported)Changes in visual function
Change in contrast sensitivity, color vision and macular perimetry thresholds
At baseline and again at six months
Changes in serum markers
At baseline and again at six months
Changes in retinal structure
At baseline and again at 6 months
subjects receiving active supplement and with no retinopathy based on clinical examination
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
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)
Chous Eye Care Associates
Tacoma, Washington, 98466, United States
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.
Alan P. Chous, O.D.
Chous Eye Care Associates
70 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2012
First Posted
July 20, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Glycemic Control in Obese Diabetics Using Three Different Pen Needles
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
placebo capsules
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
January 22, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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