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Diabetes Visual Function Supplement Study (DiVFuSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646047
First Posted: July 20, 2012
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ZeaVision, LLC
July 3, 2012
July 20, 2012
January 22, 2015
May 2012
August 2014   (Final data collection date for primary outcome measure)
Changes in visual function [ Time Frame: At baseline and again at six months ]
Change in contrast sensitivity, color vision and macular perimetry thresholds
Changes in visual function and retinal structure [ Time Frame: At baseline and again at six months ]
Changes in visual function as reflected by visual acuity, contrast sensitivity, color vision, macular perimetry, macular pigment optical density; changes in retinal structure as reflected by optical coherence tomography
Complete list of historical versions of study NCT01646047 on ClinicalTrials.gov Archive Site
  • 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)
  • Changes in retinal structure [ Time Frame: At baseline and again at 6 months ]
    Changes in optical coherence tomography and macular pigment optical density
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)
Not Provided
Not Provided
 
Diabetes Visual Function Supplement Study
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

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
  • Diabetes Mellitus - Type 1
  • Diabetes Mellitus - Type 2
  • Non-proliferative Diabetic Retinopathy
  • 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
    Other Name: two placebo capsules per day for six months
  • Experimental: supplement - no retinopathy
    subjects receiving active supplement and with no retinopathy based on clinical examination
    Intervention: Dietary Supplement: multi-component nutritional supplement capsules
  • Placebo Comparator: placebo - no retinopathy
    patients receiving placebo and who have no diabetic retinopathy based on clinical examination
    Intervention: Dietary Supplement: multi-component dietary supplement
  • Experimental: supplement - retinopathy
    patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
    Intervention: Dietary Supplement: multi-component nutritional supplement capsules
  • Placebo Comparator: placebo - retinopathy
    patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
    Intervention: Dietary Supplement: multi-component dietary supplement
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01646047
20112190
Yes
Not Provided
Not Provided
ZeaVision, LLC
ZeaVision, LLC
Not Provided
Principal Investigator: Alan P. Chous, O.D. Chous Eye Care Associates
ZeaVision, LLC
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP