Diabetes Mellitus - Type 1DiVFuSSNCT01646047
Diabetes Visual Function Supplement Study
A study testing multi-component nutritional supplement capsules and multi-component dietary supplement in people with Diabetes Mellitus - Type 1 and Diabetes Mellitus - Type 2, run by ZeaVision, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy
- What is being tested?
- multi-component nutritional supplement capsules and multi-component dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus diagnosed at least 5 years
- age greater than or equal to 18 years
- English speaker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
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
Read the 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.
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy
- Being tested
- multi-component nutritional supplement capsules, multi-component dietary supplement
- Keywords
- diabetes, diabetic retinopathy, nutritional supplements, visual function, macular pigment, macular threshold sensitivity, contrast sensitivity, color vision, optical coherence tomography
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
multi-component dietary supplementDietary supplement
Also called two placebo capsules per day for six months
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| supplement - no retinopathy | Experimental | subjects receiving active supplement and with no retinopathy based on clinical examination Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: multi-component dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual function
Change in contrast sensitivity, color vision and macular perimetry thresholds
Measured: At baseline and again at six months
Secondary outcomes (2)
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)
Measured: At baseline and again at six months
Changes in retinal structure
Changes in optical coherence tomography and macular pigment optical density
Measured: At baseline and again at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus - Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZeaVision, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan P. Chous, O.D., Principal investigator, Chous Eye Care Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646047
- Sponsor's protocol ID
- 20112190
- Acronym
- DiVFuSS
- Status last verified
- Jan 2015
- First submitted
- 3 Jul 2012
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32990945Chous 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.
PubMed 26089210
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01646047
- Acronym / sponsor ID
- DiVFuSS / 20112190
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Non-proliferative Diabetic Retinopathy
- Keywords
- diabetes, diabetic retinopathy, nutritional supplements, visual function, macular pigment, macular threshold sensitivity, contrast sensitivity, color vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ZeaVision, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| supplement - no retinopathy | Experimental | Dietary Supplement: multi-component nutritional supplement capsulessubjects receiving active supplement and with no retinopathy based on clinical examination |
| placebo - no retinopathy | Placebo comparator | Dietary Supplement: multi-component dietary supplementpatients receiving placebo and who have no diabetic retinopathy based on clinical examination |
| supplement - retinopathy | Experimental | Dietary Supplement: multi-component nutritional supplement capsulespatients receiving the active supplement and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination |
| placebo - retinopathy | Placebo comparator | Dietary Supplement: multi-component dietary supplementpatients receiving placebo and who have mild to moderate non-proliferative diabetic retinopathy based on clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes mellitus diagnosed at least 5 years
- age greater than or equal to 18 years
- English speaker
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-component nutritional supplement capsulestwo 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) | Dietary supplement | supplement - no retinopathy, supplement - retinopathy |
| multi-component dietary supplementAlso: two placebo capsules per day for six monthsplacebo capsules | Dietary supplement | placebo - no retinopathy, placebo - retinopathy |
Primary outcome
Changes in visual function
Time frame: At baseline and again at six months
Change in contrast sensitivity, color vision and macular perimetry thresholds
2 secondary outcomes
Changes in serum markers
Time frame: At baseline and again at six months
Changes in retinal structure
Time frame: At baseline and again at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Derived from this study: PubMed 32990945Robertson 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.
- Derived from this study: PubMed 26089210Chous 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan P. Chous, O.D. principal investigator
Chous Eye Care Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-component nutritional supplement capsules and multi-component dietary supplement in people with Diabetes Mellitus - Type 1 and Diabetes Mellitus - Type 2, run by ZeaVision, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visual function (time frame: At baseline and again at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01646047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.