Diabetes Visual Function Supplement Study

Non-proliferative Diabetic Retinopathy Clinical Trial

— DiVFuSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646047
• Other study ID #: 20112190
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: January 20, 2015
• Start date: May 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: ZeaVision, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

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)
• multi-component dietary supplement
placebo capsules

Locations

Country	Name	City	State
United States	Chous Eye Care Associates	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ZeaVision, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual function	Change in contrast sensitivity, color vision and macular perimetry thresholds	At baseline and again at six months	No
Secondary	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)	At baseline and again at six months	No
Secondary	Changes in retinal structure	Changes in optical coherence tomography and macular pigment optical density	At baseline and again at 6 months	No