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

Primary Purpose

Visual Field Defect, Peripheral, Glaucoma, Open-Angle

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin B3

Pyruvate

Placebo

About this trial

This is an interventional other trial for Visual Field Defect, Peripheral focused on measuring Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nicotinamide and Pyruvate (N&P)

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03797469

First Posted

May 28, 2018

Last Updated

November 9, 2021

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03797469

Brief Title

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

Official Title

Nutritional Supplements and Performance During Visual Field Testing

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visual Field Defect, Peripheral, Glaucoma, Open-Angle

Keywords

Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotinamide and Pyruvate (N&P)

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin B3

Other Intervention Name(s)

B-3 Nicotinamide

Intervention Description

3 tablets of 1000 mg each will be administered orally.

Intervention Type

Dietary Supplement

Intervention Name(s)

Pyruvate

Other Intervention Name(s)

Calcium Pyruvate

Intervention Description

2 tablets of 1500 mg each will be administered orally.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in 24-2 visual field test

Description

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 Outcome Measure Information:

Title

Change in Montreal Cognitive Assessment (MoCA) scores

Description

Time Frame

Up to 20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey M Liebmann, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29497468

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.

Results Reference

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PubMed Identifier

29295624

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.

Results Reference

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PubMed Identifier

28858158

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.

Results Reference

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PubMed Identifier

28538117

Citation

Liebmann JM, Cioffi GA. Nicking Glaucoma with Nicotinamide? N Engl J Med. 2017 May 25;376(21):2079-2081. doi: 10.1056/NEJMcibr1702486. No abstract available.

Results Reference

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PubMed Identifier

28487632

Citation

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

Results Reference

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PubMed Identifier

28209901

Citation

Williams PA, Harder JM, Foxworth NE, Cochran KE, Philip VM, Porciatti V, Smithies O, John SW. Vitamin B3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice. Science. 2017 Feb 17;355(6326):756-760. doi: 10.1126/science.aal0092.

Results Reference

background

PubMed Identifier

34792559

Citation

De Moraes CG, John SWM, Williams PA, Blumberg DM, Cioffi GA, Liebmann JM. Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle Glaucoma: A Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jan 1;140(1):11-18. doi: 10.1001/jamaophthalmol.2021.4576.

Results Reference

derived

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

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