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

Columbia University32 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Visual Field Defect, Peripheral Glaucoma, Open-Angle

Interventions

Vitamin B3DIETARY_SUPPLEMENT

3 tablets of 1000 mg each will be administered orally.

PyruvateDIETARY_SUPPLEMENT

2 tablets of 1500 mg each will be administered orally.

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 20 weeks

Secondary Outcomes

Change in Montreal Cognitive Assessment (MoCA) scores

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.

Time frame: Up to 20 weeks

Data from ClinicalTrials.gov

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