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Completed

NCT Number: NCT03797469

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

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B3

Dietary Supplement

3 tablets of 1000 mg each will be administered orally.

Other names: B-3 Nicotinamide

Pyruvate

Dietary Supplement

2 tablets of 1500 mg each will be administered orally.

Other names: Calcium Pyruvate

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Nutritional Supplements and Performance During Visual Field Testing

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2019
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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