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Diabetes Visual Function Supplement Study (DiVFuSS)

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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

Tracking Information
First Submitted Date  ICMJE July 3, 2012
First Posted Date  ICMJE July 20, 2012
Last Update Posted Date January 22, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Changes in visual function [ Time Frame: At baseline and again at six months ]
Change in contrast sensitivity, color vision and macular perimetry thresholds
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes Visual Function Supplement Study
Official Title  ICMJE Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes Mellitus - Type 1
  • Diabetes Mellitus - Type 2
  • Non-proliferative Diabetic Retinopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
70
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)
75
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01646047
Other Study ID Numbers  ICMJE 20112190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZeaVision, LLC
Study Sponsor  ICMJE ZeaVision, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan P. Chous, O.D. Chous Eye Care Associates
PRS Account ZeaVision, LLC
Verification Date January 2015

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