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Diabetes Visual Function Supplement Study (DiVFuSS)

This study is currently recruiting participants.
Verified July 2012 by ZeaVision, LLC
Sponsor:
Information provided by (Responsible Party):
ZeaVision, LLC
ClinicalTrials.gov Identifier:
NCT01646047
First received: July 3, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZeaVision, LLC:

Primary Outcome Measures:
  • Changes in visual function [ Time Frame: At baseline and again at six months ] [ Designated as safety issue: No ]
    Change in contrast sensitivity, color vision and macular perimetry thresholds


Secondary Outcome Measures:
  • Changes in serum markers [ Time Frame: At baseline and again at six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in optical coherence tomography and macular pigment optical density


Estimated Enrollment: 75
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646047

Contacts
Contact: Alan P. Chous, O.D. 425-736-6251 dr.chous@diabeticeyes.com
Contact: Jay M. Haynie, O.D. 253-272-9245 JayH@retina-macula.com

Locations
United States, Washington
Chous Eye Care Associates Recruiting
Tacoma, Washington, United States, 98466
Contact: Alan P. Chous, O.D.     425-736-6251     dr.chous@diabeticeyes.com    
Contact: Jay M. Haynie, O.D.     253-272-9245     JayH@retina-macula.com    
Principal Investigator: Alan P. Chous, O.D.            
Sponsors and Collaborators
ZeaVision, LLC
Investigators
Principal Investigator: Alan P. Chous, O.D. Chous Eye Care Associates
  More Information

No publications provided

Responsible Party: ZeaVision, LLC
ClinicalTrials.gov Identifier: NCT01646047     History of Changes
Other Study ID Numbers: 20112190
Study First Received: July 3, 2012
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

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:
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013