Diabetes Visual Function Supplement Study (DiVFuSS)

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

Tracking Information

• First Submitted Date: July 3, 2012
• First Posted Date: July 20, 2012
• Last Update Posted Date: January 22, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Diabetes Visual Function Supplement Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Supportive Care

Condition

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

Intervention

• 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

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 20, 2015): 70
• Original Estimated Enrollment (submitted: July 17, 2012): 75
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01646047
• Other Study ID Numbers: 20112190
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: ZeaVision, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: ZeaVision, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alan P. Chous, O.D.; Chous Eye Care Associates

• PRS Account: ZeaVision, LLC
• Verification Date: January 2015