Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study

November 10, 2025 updated by: Aakriti G. Shukla, Columbia University

The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma.

A total of up to 188 participants will be enrolled and randomized 1:1 to receive N&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing or standard automated perimetry (SAP). The natural course of glaucoma includes a decline in visual function that matches optic nerve structural changes over time.

Both in clinical practice and in clinical trials, individuals undergo visual field testing at regular intervals in order to define whether progressive changes have occurred as well as the rapidity of change. Visual field results are highly variable within and between sessions, partly due to its subjective nature, which ultimately depends upon the test reliability, individuals' level of experience with the test, variability due to disease severity, and, importantly, the level of individual attentiveness during the test. Therefore, numerous attempts have been made to try to optimize individuals' performance during the test. Some of the approaches reported to date are listening to classical music mitigating background noise and use of nutritional supplements.

Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. The investigators are doing this research study to find out if taking nutritional supplements (vitamin B3 and pyruvate) available over- the-counter can help slow the rate of glaucomatous visual field progression compared to placebo.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Stanford University Department of Ophthalmology
    • New York
      • New York, New York, United States, 10022
        • ColumbiaDoctors Ophthalmology - 880 Third Avenue
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center - 622 W 168th St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. Willing and able to provide informed consent for participation in the study.
  2. Between 35 and 85 years of age.
  3. Only one eligible eye per patient will be enrolled. If both eyes qualify, study eye will be elected based on the following characteristics (in order of most to least important): 1) disc hemorrhage, 2) higher intraocular pressure (IOP), 3) without previous filtering surgery, 4) better visual acuity. If both eyes meet these four criteria equally, then the study eye will be determined by random assignment.
  4. Have a confirmed diagnosis of primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
  5. If there is a prior reliable 24-2, the MD should be better than -20dB.
  6. Able to perform reliable visual field testing with 24-2 Swedish Interactive Threshold Algorithm (SITA)-Standard SAP (defined as false positive rates <15%, false negative rates <30%) at the most recent office visit.
  7. Have best corrected visual acuity better than or equal to 20/40 in the study eye.
  8. Have an IOP (treated or untreated) ≥ 14 mmHg and within 24 months of the baseline visit and one instance of historical IOP ≥ 16 mmHg by patient report or chart.

Exclusion Criteria

  1. Glaucoma or cataract surgery anticipated in the next 18 months.
  2. Have a diagnosis of significant cataract or media opacity affecting the visual field test or imaging studies.
  3. Have a diagnosis of dementia, Alzheimer's, or other neurological disease.
  4. Have an inability to take or intolerance to nicotinamide and/or pyruvate.
  5. Have undergone incisional glaucoma surgery (trabeculectomy, glaucoma drainage implant, or Xen Gel Stent) within the last 12 months. Phacoemulsification ± canalicular micro-invasive glaucoma surgery (MIGS) is acceptable if performed ≥ 4 months prior to study entry.
  6. Prior complicated cataract surgery (e.g., vitrectomy, etc)
  7. Have a functioning trabeculectomy, glaucoma drainage implant, or Xen Gel Stent (defined as being on 0-1 glaucoma medications). If these surgeries have failed and the patient is on ≥ 2 classes of glaucoma medication and meets all other entry criteria, he/she is eligible).
  8. Retinal pathology that significantly affects visual acuity (worse than 20/40) or visual field.
  9. Refractive disorders and disorders other than glaucoma known to affect the visual field (VF) and macular optical coherence tomography (OCT) imaging (e.g., epiretinal membrane, cystoid macular edema, pathologic myopia, cylinder > 3 diopters, prior history of pars plana vitrectomy with internal limiting membrane peel).
  10. IOP at screening or baseline visit ≥ 25 mmHg.
  11. Have a known history of liver disease.
  12. Are pregnant or are planning to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotinamide and Pyruvate
The N&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).
Drug: Dietary supplements - Nicotinamide and Pyruvate
Nutritional supplements
Placebo Comparator: Placebo
The placebo group will receive placebo for 87 weeks (20 months).
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in retinal nerve fiber and ganglion cell layer thickness
Time Frame: 87 weeks
The primary outcome in this study are changes in retinal nerve fiber and ganglion cell layer thickness as assessed by optical coherence tomography testing between intervention and placebo groups.
87 weeks
Change in visual field results based on pointwise and global metrics
Time Frame: 87 weeks
The primary outcome in this study are changes in visual field results based on pointwise and global metrics between intervention and placebo groups.
87 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Stanford University

Investigators

  • Principal Investigator: Aakriti G. Shukla, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU0211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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