Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)

NCT03797469 | Completed

• 1 other identifier: AAAR8208
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.

Conditions

Visual Field Defect, Peripheral; Glaucoma, Open-Angle

Keywords

Perimetry; Vitamins; Glaucoma; Supplements; Vitamin B3; Nicotinamide

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 weeks

Secondary Outcomes (1)

• Change in Montreal Cognitive Assessment (MoCA) scores

  Up to 20 weeks

Study Arms (2)

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.

Dietary Supplement: Vitamin B3; Dietary Supplement: Pyruvate

Placebo

PLACEBO COMPARATOR

This group will receive an equal number of tablets as the N\&P group.

Dietary Supplement: Placebo

Interventions

Vitamin B3 DIETARY_SUPPLEMENT

3 tablets of 1000 mg each will be administered orally.

Also known as: B-3 Nicotinamide

Nicotinamide and Pyruvate (N&P)

Pyruvate DIETARY_SUPPLEMENT

2 tablets of 1500 mg each will be administered orally.

Also known as: Calcium Pyruvate

Nicotinamide and Pyruvate (N&P)

Placebo DIETARY_SUPPLEMENT

Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (7)

• 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.

  PMID: 29497468 BACKGROUND

• 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.

  PMID: 29295624 BACKGROUND

• 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.

  PMID: 28858158 BACKGROUND

• 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.

  PMID: 28538117 BACKGROUND

• 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.

  PMID: 28487632 BACKGROUND

• 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.

  PMID: 28209901 BACKGROUND

• 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.

  PMID: 34792559 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Niacinamide; Pyruvic Acid

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pyruvates; Keto Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Jeffrey M Liebmann, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: January 9, 2019
• Study Start: April 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)