Diabetes Visual Function Supplement Study (DiVFuSS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01646047 |
Recruitment Status :
Completed
First Posted : July 20, 2012
Last Update Posted : January 22, 2015
|
Sponsor:
ZeaVision, LLC
Information provided by (Responsible Party):
ZeaVision, LLC
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | July 3, 2012 | |||
First Posted Date ICMJE | July 20, 2012 | |||
Last Update Posted Date | January 22, 2015 | |||
Study Start Date ICMJE | May 2012 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Changes in visual function [ Time Frame: At baseline and again at six months ] Change in contrast sensitivity, color vision and macular perimetry thresholds
|
|||
Original Primary Outcome Measures ICMJE |
Changes in visual function and retinal structure [ Time Frame: At baseline and again at six months ] Changes in visual function as reflected by visual acuity, contrast sensitivity, color vision, macular perimetry, macular pigment optical density; changes in retinal structure as reflected by optical coherence tomography
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
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)
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Diabetes Visual Function Supplement Study | |||
Official Title ICMJE | Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Supportive Care |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
70 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date ICMJE | September 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01646047 | |||
Other Study ID Numbers ICMJE | 20112190 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | ZeaVision, LLC | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | ZeaVision, LLC | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | ZeaVision, LLC | |||
Verification Date | January 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |