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Diabetes Visual Function Supplement Study (DiVFuSS)

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.
 
ClinicalTrials.gov Identifier: NCT01646047
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
ZeaVision, LLC

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus - Type 1 Diabetes Mellitus - Type 2 Non-proliferative Diabetic Retinopathy Dietary Supplement: multi-component nutritional supplement capsules Dietary Supplement: multi-component dietary supplement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
Study Start Date : May 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: supplement - no retinopathy
subjects receiving active supplement and with no retinopathy based on clinical examination
 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)
Placebo Comparator: placebo - no retinopathy
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
 Dietary Supplement: multi-component dietary supplement
placebo capsules
Other Name: two placebo capsules per day for six months
Experimental: supplement - retinopathy
patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
 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)
Placebo Comparator: placebo - retinopathy
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
 Dietary Supplement: multi-component dietary supplement
placebo capsules
Other Name: two placebo capsules per day for six months


Outcome Measures
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Primary Outcome Measures :
  1. Changes in visual function [ Time Frame: At baseline and again at six months ]
    Change in contrast sensitivity, color vision and macular perimetry thresholds


Secondary Outcome Measures :
  1. 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)

  2. Changes in retinal structure [ Time Frame: At baseline and again at 6 months ]
    Changes in optical coherence tomography and macular pigment optical density


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646047


Locations
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United States, Washington
Chous Eye Care Associates
Tacoma, Washington, United States, 98466
Sponsors and Collaborators
ZeaVision, LLC
Investigators
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Principal Investigator: Alan P. Chous, O.D. Chous Eye Care Associates
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ZeaVision, LLC
ClinicalTrials.gov Identifier: NCT01646047    
Other Study ID Numbers: 20112190
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by ZeaVision, LLC:
diabetes
diabetic retinopathy
nutritional supplements
visual function
macular pigment
 macular threshold sensitivity
contrast sensitivity
color vision
optical coherence tomography
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications