Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
NCT ID: NCT03797469
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2019-04-15
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Nicotinamide and Pyruvate (N&P)
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.
Vitamin B3
3 tablets of 1000 mg each will be administered orally.
Pyruvate
2 tablets of 1500 mg each will be administered orally.
Placebo
This group will receive an equal number of tablets as the N\&P group.
Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
Interventions
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Vitamin B3
3 tablets of 1000 mg each will be administered orally.
Pyruvate
2 tablets of 1500 mg each will be administered orally.
Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
80 Years
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Jeffrey Liebmann
Professor of Ophthalmology
Principal Investigators
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Jeffrey M Liebmann, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AAAR8208
Identifier Type: -
Identifier Source: org_study_id