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Diabetes Visual Function Supplement Study (DiVFuSS)

Primary Purpose

Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multi-component nutritional supplement capsules
multi-component dietary supplement
Sponsored by
ZeaVision, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus - Type 1 focused on measuring diabetes, diabetic retinopathy, nutritional supplements, visual function, macular pigment, macular threshold sensitivity, contrast sensitivity, color vision, optical coherence tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chous Eye Care Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

supplement - no retinopathy

placebo - no retinopathy

supplement - retinopathy

placebo - retinopathy

Arm Description

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

patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination

Outcomes

Primary Outcome Measures

Changes in visual function
Change in contrast sensitivity, color vision and macular perimetry thresholds

Secondary Outcome Measures

Changes in serum markers
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
Changes in optical coherence tomography and macular pigment optical density

Full Information

First Posted
July 3, 2012
Last Updated
January 20, 2015
Sponsor
ZeaVision, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01646047
Brief Title
Diabetes Visual Function Supplement Study
Acronym
DiVFuSS
Official Title
Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZeaVision, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy
Keywords
diabetes, diabetic retinopathy, nutritional supplements, visual function, macular pigment, macular threshold sensitivity, contrast sensitivity, color vision, optical coherence tomography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supplement - no retinopathy
Arm Type
Experimental
Arm Description
subjects receiving active supplement and with no retinopathy based on clinical examination
Arm Title
placebo - no retinopathy
Arm Type
Placebo Comparator
Arm Description
patients receiving placebo and who have no diabetic retinopathy based on clinical examination
Arm Title
supplement - retinopathy
Arm Type
Experimental
Arm Description
patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
Arm Title
placebo - retinopathy
Arm Type
Placebo Comparator
Arm Description
patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
Intervention Type
Dietary Supplement
Intervention Name(s)
multi-component nutritional supplement capsules
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
multi-component dietary supplement
Other Intervention Name(s)
two placebo capsules per day for six months
Intervention Description
placebo capsules
Primary Outcome Measure Information:
Title
Changes in visual function
Description
Change in contrast sensitivity, color vision and macular perimetry thresholds
Time Frame
At baseline and again at six months
Secondary Outcome Measure Information:
Title
Changes in serum markers
Description
Changes in glycosylated hemoglobin, serum lipids, serum vitamin D (all subjects) and the serum inflammatory cytokine, tumor necrosis factor-alpha (subjects with retinopathy)
Time Frame
At baseline and again at six months
Title
Changes in retinal structure
Description
Changes in optical coherence tomography and macular pigment optical density
Time Frame
At baseline and again at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan P. Chous, O.D.
Organizational Affiliation
Chous Eye Care Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chous Eye Care Associates
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98466
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32990945
Citation
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.
Results Reference
derived
PubMed Identifier
26089210
Citation
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.
Results Reference
derived

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Diabetes Visual Function Supplement Study

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