NCT01646047

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

July 3, 2012

Last Update Submit

January 20, 2015

Conditions

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

Keywords

diabetesdiabetic retinopathynutritional supplementsvisual functionmacular pigmentmacular threshold sensitivitycontrast sensitivitycolor visionoptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Changes in visual function

    Change in contrast sensitivity, color vision and macular perimetry thresholds

    At baseline and again at six months

Secondary Outcomes (2)

  • Changes in serum markers

    At baseline and again at six months

  • Changes in retinal structure

    At baseline and again at 6 months

Study Arms (4)

supplement - no retinopathy

EXPERIMENTAL

subjects receiving active supplement and with no retinopathy based on clinical examination

Dietary Supplement: multi-component nutritional supplement capsules

placebo - no retinopathy

PLACEBO COMPARATOR

patients receiving placebo and who have no diabetic retinopathy based on clinical examination

Dietary Supplement: multi-component dietary supplement

supplement - retinopathy

EXPERIMENTAL

patients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination

Dietary Supplement: multi-component nutritional supplement capsules

placebo - retinopathy

PLACEBO COMPARATOR

patients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination

Dietary Supplement: multi-component dietary supplement

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)

supplement - no retinopathysupplement - retinopathy
multi-component dietary supplementDIETARY_SUPPLEMENT

placebo capsules

Also known as: two placebo capsules per day for six months
placebo - no retinopathyplacebo - retinopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus diagnosed at least 5 years
  • age greater than or equal to 18 years
  • English speaker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chous Eye Care Associates

Tacoma, Washington, 98466, United States

Location

Related Publications (2)

  • Robertson NU, Schoonees A, Brand A, Visser J. Pine bark (Pinus spp.) extract for treating chronic disorders. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD008294. doi: 10.1002/14651858.CD008294.pub5.

    PMID: 32990945DERIVED

  • 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.

    PMID: 26089210DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Alan P. Chous, O.D.

    Chous Eye Care Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 20, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

US(1)