Diabetes Visual Function Supplement Study

ZeaVision, LLC70 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

multi-component nutritional supplement capsulesDIETARY_SUPPLEMENT

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)

multi-component dietary supplementDIETARY_SUPPLEMENT

placebo capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chous Eye Care Associates

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Changes in visual function

Change in contrast sensitivity, color vision and macular perimetry thresholds

Time frame: At baseline and again at six months

Secondary Outcomes

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)

Time frame: At baseline and again at six months

Changes in retinal structure

Changes in optical coherence tomography and macular pigment optical density

Time frame: At baseline and again at 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.