Visual Field Defect, PeripheralNCT03797469
Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
A study testing Vitamin B3 and Pyruvate in people with Visual Field Defect, Peripheral and Glaucoma, Open-Angle, run by Columbia University at 1 site in United States.
Trial summary
This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Field Defect, Peripheral, Glaucoma, Open-Angle
- What is being tested?
- Vitamin B3 and Pyruvate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 31 Dec 2020
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of primary open-angle glaucoma;
- Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes;
- Best corrected visual acuity better than 20/40 in both eyes;
- Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).
Who cannot join
- Significant cataract or media opacity;
- Diagnosis of dementia, Alzheimer's, and other neurological diseases;
- Current use or use in the past 1 month of nutritional supplements;
- Inability to take or intolerance to nicotinamide and/or pyruvate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Nutritional Supplements and Performance During Visual Field Testing
This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.
Read the detailed description
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.
- Being tested
- Vitamin B3, Pyruvate, Placebo
- Keywords
- Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B3Dietary supplement
Also called B-3 Nicotinamide
3 tablets of 1000 mg each will be administered orally.
PyruvateDietary supplement
Also called Calcium Pyruvate
2 tablets of 1500 mg each will be administered orally.
PlaceboDietary supplement
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide and Pyruvate (N&P) | Active comparator | This group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate. Receives: Dietary Supplement: Vitamin B3; Dietary Supplement: Pyruvate |
| Placebo | Placebo comparator | This group will receive an equal number of tablets as the N\&P group. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-2 visual field test
Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared.
Measured: Up to 20 weeks
Secondary outcomes (1)
Change in Montreal Cognitive Assessment (MoCA) scores
Montreal Cognitive Assessment (MoCA) score before and after intervention and correlate these changes with those seen on visual field tests will be compared. The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that assesses different types of cognitive abilities. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start15 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Visual Field Defect, PeripheralStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Liebmann, Columbia University
- Investigators
- Jeffrey M Liebmann, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797469
- Sponsor's protocol ID
- AAAR8208
- Status last verified
- Nov 2021
- First submitted
- 28 May 2018
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams PA, Harder JM, Cardozo BH, Foxworth NE, John SWM. Nicotinamide treatment robustly protects from inherited mouse glaucoma. Commun Integr Biol. 2018 Jan 19;11(1):e1356956. doi: 10.1080/19420889.2017.1356956. eCollection 2018.
PubMed 29497468Zhang M, Ying W. NAD+ Deficiency Is a Common Central Pathological Factor of a Number of Diseases and Aging: Mechanisms and Therapeutic Implications. Antioxid Redox Signal. 2019 Feb 20;30(6):890-905. doi: 10.1089/ars.2017.7445. Epub 2018 Feb 7.
PubMed 29295624Williams PA, Harder JM, John SWM. Glaucoma as a Metabolic Optic Neuropathy: Making the Case for Nicotinamide Treatment in Glaucoma. J Glaucoma. 2017 Dec;26(12):1161-1168. doi: 10.1097/IJG.0000000000000767.
PubMed 28858158Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. No abstract available.
PubMed 28538117Williams PA, Harder JM, Foxworth NE, Cardozo BH, Cochran KE, John SWM. Nicotinamide and WLDS Act Together to Prevent Neurodegeneration in Glaucoma. Front Neurosci. 2017 Apr 25;11:232. doi: 10.3389/fnins.2017.00232. eCollection 2017.
PubMed 28487632Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092.
PubMed 28209901De Moraes CG, John SWM, Williams PA, Blumberg DM, Cioffi GA, Liebmann JM. Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle Glaucoma: A Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jan 1;140(1):11-18. doi: 10.1001/jamaophthalmol.2021.4576.
PubMed 34792559
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplements and Performance During Visual Field Testing
- ClinicalTrials.gov ID
- NCT03797469
- Acronym / sponsor ID
- AAAR8208
- Keywords
- Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Jan 2019 (actual)
- 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 seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.
Detailed description
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide and Pyruvate (N&P) | Active comparator | Dietary Supplement: Vitamin B3, Dietary Supplement: PyruvateThis group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group will receive an equal number of tablets as the N\&P group. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of primary open-angle glaucoma;
- Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes;
- Best corrected visual acuity better than 20/40 in both eyes;
- Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).
Key exclusion criteria (4 listed)
- Significant cataract or media opacity;
- Diagnosis of dementia, Alzheimer's, and other neurological diseases;
- Current use or use in the past 1 month of nutritional supplements;
- Inability to take or intolerance to nicotinamide and/or pyruvate.
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 |
|---|---|---|
| Vitamin B3Also: B-3 Nicotinamide3 tablets of 1000 mg each will be administered orally. | Dietary supplement | Nicotinamide and Pyruvate (N&P) |
| PyruvateAlso: Calcium Pyruvate2 tablets of 1500 mg each will be administered orally. | Dietary supplement | Nicotinamide and Pyruvate (N&P) |
| PlaceboTablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided. | Dietary supplement | Placebo |
Primary outcome
Change in 24-2 visual field test
Time frame: Up to 20 weeks
Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared.
1 secondary outcome
Change in Montreal Cognitive Assessment (MoCA) scores
Time frame: Up to 20 weeks
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 11 Nov 2021.
- Background: PubMed 29497468Williams PA, Harder JM, Cardozo BH, Foxworth NE, John SWM. Nicotinamide treatment robustly protects from inherited mouse glaucoma. Commun Integr Biol. 2018 Jan 19;11(1):e1356956. doi: 10.1080/19420889.2017.1356956. eCollection 2018.
- Background: PubMed 29295624Zhang M, Ying W. NAD+ Deficiency Is a Common Central Pathological Factor of a Number of Diseases and Aging: Mechanisms and Therapeutic Implications. Antioxid Redox Signal. 2019 Feb 20;30(6):890-905. doi: 10.1089/ars.2017.7445. Epub 2018 Feb 7.
- Background: PubMed 28858158Williams PA, Harder JM, John SWM. Glaucoma as a Metabolic Optic Neuropathy: Making the Case for Nicotinamide Treatment in Glaucoma. J Glaucoma. 2017 Dec;26(12):1161-1168. doi: 10.1097/IJG.0000000000000767.
- Background: PubMed 28538117Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. No abstract available.
- Background: PubMed 28487632Williams PA, Harder JM, Foxworth NE, Cardozo BH, Cochran KE, John SWM. Nicotinamide and WLDS Act Together to Prevent Neurodegeneration in Glaucoma. Front Neurosci. 2017 Apr 25;11:232. doi: 10.3389/fnins.2017.00232. eCollection 2017.
- Background: PubMed 28209901Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092.
- Derived from this study: PubMed 34792559De Moraes CG, John SWM, Williams PA, Blumberg DM, Cioffi GA, Liebmann JM. Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle Glaucoma: A Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jan 1;140(1):11-18. doi: 10.1001/jamaophthalmol.2021.4576.
- Individual participant dataSharing planned: No
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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.
Jeffrey M Liebmann, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B3 and Pyruvate in people with Visual Field Defect, Peripheral and Glaucoma, Open-Angle, run by Columbia University 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 4 inclusion and 4 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 11 Nov 2021. 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?
Change in 24-2 visual field test (time frame: Up to 20 weeks). 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 NCT03797469, which also lists 7 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 11 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.