Clinical trial NCT03797469: Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
Official title: Nutritional Supplements and Performance During Visual Field Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Field Defect, Peripheral
Glaucoma, Open-Angle
Keywords: Perimetry
Vitamins
Glaucoma
Supplements
Vitamin B3
Nicotinamide
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in 24-2 visual field test
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) scores
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jeffrey M Liebmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zhang 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.
citation: Williams 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.
citation: Liebmann 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.
citation: Williams 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.
citation: Williams 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.
citation: De 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.