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

Columbia University

Status: Completed

Conditions: Visual Field Defect, Peripheral; Glaucoma, Open-Angle

Treatments: Dietary Supplement: Vitamin B3; Dietary Supplement: Placebo; Dietary Supplement: Pyruvate

Study type: Interventional

Funder types: Other

Identifiers

NCT03797469

AAAR8208

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 2 patient groups, including a placebo group

Nicotinamide and Pyruvate (N&P)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Pyruvate

Dietary Supplement: Vitamin B3

Placebo

Placebo Comparator group

Description:

This group will receive an equal number of tablets as the N\&P group.

Treatment:

Dietary Supplement: Placebo