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Completed

NCT Number: NCT01646047

Diabetes Visual Function Supplement Study

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

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Key information

Conditions

Diabetes Mellitus - Type 1 Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus - Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Non-Proliferative Diabetic Retinopathy Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chous Eye Care Associates

Tacoma, Washington, 98466, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-component nutritional supplement capsules

Dietary 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 supplement

Dietary Supplement

placebo capsules

Other names: two placebo capsules per day for six months

Primary outcomes

  1. Changes in visual function

    Time frame: At baseline and again at six months

    Change in contrast sensitivity, color vision and macular perimetry thresholds

Secondary outcomes

  1. 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)

  2. Changes in retinal structure

    Time frame: At baseline and again at 6 months

    Changes in optical coherence tomography and macular pigment optical density

Sponsors and collaborators

Lead sponsor

ZeaVision, LLC

Industry

Registry information

Official study title

Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy

Acronym: DiVFuSS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2012
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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