Diabetes Visual Function Supplement Study

Not Applicable

Completed

• Conditions: Non-proliferative Diabetic Retinopathy; Diabetes Mellitus - Type 2; Diabetes Mellitus - Type 1
• Interventions: Dietary Supplement: multi-component nutritional supplement capsules; Dietary Supplement: multi-component dietary supplement

• Registration Number: NCT01646047
• Lead Sponsor: ZeaVision, LLC

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supplement - no retinopathy	multi-component nutritional supplement capsules	subjects receiving active supplement and with no retinopathy based on clinical examination
placebo - retinopathy	multi-component dietary supplement	patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination
placebo - no retinopathy	multi-component dietary supplement	patients receiving placebo and who have no diabetic retinopathy based on clinical examination
supplement - retinopathy	multi-component nutritional supplement capsules	patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination

Primary Outcome Measures

Name	Time	Method
Changes in visual function	At baseline and again at six months	Change in contrast sensitivity, color vision and macular perimetry thresholds

Secondary Outcome Measures

Name	Time	Method
Changes in serum markers	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	At baseline and again at 6 months	Changes in optical coherence tomography and macular pigment optical density

Trial Locations

Locations (1)

Chous Eye Care Associates; 🇺🇸 Tacoma, Washington, United States