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

Glaucoma, Open-Angle Clinical Trial

Official title:

Nutritional Supplements and Performance During Visual Field Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797469
• Other study ID #: AAAR8208
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Vitamin B3
3 tablets of 1000 mg each will be administered orally.
• Pyruvate
2 tablets of 1500 mg each will be administered orally.
• Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. — View Citation

Williams PA, Harder JM, Cardozo BH, Foxworth NE, John SWM. Nicotinamide treatment robustly protects from inherited mouse glaucoma. Commun Integr Biol. 2018 Jan 19;11(1):e1356956. doi: 10.1080/19420889.2017.1356956. eCollection 2018. — View Citation

Williams PA, Harder JM, Foxworth NE, Cardozo BH, Cochran KE, John SWM. Nicotinamide and WLD(S) Act Together to Prevent Neurodegeneration in Glaucoma. Front Neurosci. 2017 Apr 25;11:232. doi: 10.3389/fnins.2017.00232. eCollection 2017. — View Citation

Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B(3) modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092. — View Citation

Williams PA, Harder JM, John SWM. Glaucoma as a Metabolic Optic Neuropathy: Making the Case for Nicotinamide Treatment in Glaucoma. J Glaucoma. 2017 Dec;26(12):1161-1168. doi: 10.1097/IJG.0000000000000767. Review. — View Citation

Zhang M, Ying W. NAD(+) Deficiency Is a Common Central Pathological Factor of a Number of Diseases and Aging: Mechanisms and Therapeutic Implications. Antioxid Redox Signal. 2019 Feb 20;30(6):890-905. doi: 10.1089/ars.2017.7445. Epub 2018 Feb 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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