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

November 9, 2021 updated by: Jeffrey Liebmann, Columbia University

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.

Study Overview

Status

Completed

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. 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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: Vitamin B3
3 tablets of 1000 mg each will be administered orally.
Other Names:
  • B-3 Nicotinamide
Dietary supplement: Pyruvate
2 tablets of 1500 mg each will be administered orally.
Other Names:
  • Calcium Pyruvate
Placebo Comparator: Placebo
This group will receive an equal number of tablets as the N&P group.
Dietary supplement: Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montreal Cognitive Assessment (MoCA) scores
Time Frame: Up to 20 weeks
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.
Up to 20 weeks

Collaborators and Investigators

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

Sponsor

Columbia University

Investigators

  • Principal Investigator: Jeffrey M Liebmann, 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)

April 15, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR8208

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

No

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.

Clinical Trials on Glaucoma, Open-Angle

Clinical Trials on Vitamin B3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe