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

Not Applicable

Completed

• Conditions: Visual Field Defect, Peripheral; Glaucoma, Open-Angle
• Interventions: Dietary Supplement: Vitamin B3; Dietary Supplement: Placebo; Dietary Supplement: Pyruvate

• Registration Number: NCT03797469
• Lead Sponsor: Columbia University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Study Start: 2019-04-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotinamide and Pyruvate (N&P)	Vitamin B3	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.
Nicotinamide and Pyruvate (N&P)	Pyruvate	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.
Placebo	Placebo	This group will receive an equal number of tablets as the N\&P group.

Primary Outcome Measures

Name	Time	Method
Change in 24-2 visual field test	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 Outcome Measures

Name	Time	Method
Change in Montreal Cognitive Assessment (MoCA) scores	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States