Diabetes Visual Function Supplement Study (DiVFuSS)

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	Complete list of historical versions of study NCT01646047 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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 *	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.
* 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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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