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

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

Detailed Description
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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.

Official Title
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Nutritional Supplements and Performance During Visual Field Testing

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

Intervention / Treatment
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* Dietary Supplement: Vitamin B3
* Dietary Supplement: Pyruvate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotinamide and Pyruvate (N&P)<br>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<br>* 3 tablets of 1000 mg each will be administered orally.<br>* Other names: B-3 Nicotinamide;Dietary Supplement: Pyruvate<br>* 2 tablets of 1500 mg each will be administered orally.<br>* Other names: Calcium Pyruvate;|
| Placebo Comparator: Placebo<br>This group will receive an equal number of tablets as the N&P group. | Dietary Supplement: Placebo<br>* Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide