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

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ClinicalTrials.gov Identifier: NCT03797469
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Liebmann, Columbia University

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

Condition or disease Intervention/treatment Phase
Visual Field Defect, Peripheral Glaucoma, Open-Angle Dietary Supplement: Vitamin B3 Dietary Supplement: Pyruvate Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Nutritional Supplements and Performance During Visual Field Testing
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nicotinamide and Pyruvate (N&P)
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
3 tablets of 1000 mg each will be administered orally.
Other Name: B-3 Nicotinamide

Dietary Supplement: Pyruvate
2 tablets of 1500 mg each will be administered orally.
Other Name: Calcium Pyruvate

Placebo Comparator: Placebo
This group will receive an equal number of tablets as the N&P group.
Dietary Supplement: Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.




Primary Outcome Measures :
  1. Change in 24-2 visual field test [ Time Frame: Up to 20 weeks ]
    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 :
  1. Change in Montreal Cognitive Assessment (MoCA) scores [ Time Frame: Up to 20 weeks ]
    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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797469


Contacts
Contact: Carlos Gustavo De Moraes, MD, MPH 212-342-0630 cvd2109@cumc.columbia.edu
Contact: Lisa Hark, PhD 212-342-4586 lah112@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Carlos Gustavo De Moraes, MD, MPH       cvd2109@cumc.columbia.edu   
Contact: Lisa M Hark, PhD       lah112@cumc.columbia.edu   
Principal Investigator: Jeffrey M Liebmann, MD         
Sub-Investigator: George A Cioffi, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Jeffrey M Liebmann, MD Columbia University

Publications:
Responsible Party: Jeffrey Liebmann, Professor of Ophthalmology, Columbia University
ClinicalTrials.gov Identifier: NCT03797469     History of Changes
Other Study ID Numbers: AAAR8208
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jeffrey Liebmann, Columbia University:
Perimetry
Vitamins
Glaucoma
Supplements
Vitamin B3
Nicotinamide

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Vitamins
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents