<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797469</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR8208</org_study_id>
    <nct_id>NCT03797469</nct_id>
  </id_info>
  <brief_title>Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)</brief_title>
  <official_title>Nutritional Supplements and Performance During Visual Field Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to test whether these over-the-counter nutritional supplements have an&#xD;
      impact on patients' performance during visual field testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to&#xD;
      detect progression is visual field testing. Visual field testing is the reference standard to&#xD;
      measure visual function in glaucoma. It is called called standard automated perimetry (SAP).&#xD;
      However, this test is very subjective, often unreliable, and variable. One of the main causes&#xD;
      of unreliable tests is the lack of attentiveness or concentration during the test. Previous&#xD;
      studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability&#xD;
      of this test. Recent studies have suggested that over-the-counter medications such as&#xD;
      nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test.&#xD;
      This can ultimately reduce costs due to repeated testing and increase doctor's certainty when&#xD;
      analyzing the results of this test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-2 visual field test</measure>
    <time_frame>Up to 20 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Montreal Cognitive Assessment (MoCA) scores</measure>
    <time_frame>Up to 20 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Visual Field Defect, Peripheral</condition>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>Nicotinamide and Pyruvate (N&amp;P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will receive an equal number of tablets as the N&amp;P group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin B3</intervention_name>
    <description>3 tablets of 1000 mg each will be administered orally.</description>
    <arm_group_label>Nicotinamide and Pyruvate (N&amp;P)</arm_group_label>
    <other_name>B-3 Nicotinamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pyruvate</intervention_name>
    <description>2 tablets of 1500 mg each will be administered orally.</description>
    <arm_group_label>Nicotinamide and Pyruvate (N&amp;P)</arm_group_label>
    <other_name>Calcium Pyruvate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of primary open-angle glaucoma;&#xD;
&#xD;
          -  Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels&#xD;
             (dB) and better than -12 dB in both eyes;&#xD;
&#xD;
          -  Best corrected visual acuity better than 20/40 in both eyes;&#xD;
&#xD;
          -  Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cataract or media opacity;&#xD;
&#xD;
          -  Diagnosis of dementia, Alzheimer's, and other neurological diseases;&#xD;
&#xD;
          -  Current use or use in the past 1 month of nutritional supplements;&#xD;
&#xD;
          -  Inability to take or intolerance to nicotinamide and/or pyruvate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey M Liebmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>29497468</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29295624</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28858158</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28538117</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28487632</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28209901</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Jeffrey Liebmann</investigator_full_name>
    <investigator_title>Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Perimetry</keyword>
  <keyword>Vitamins</keyword>
  <keyword>Glaucoma</keyword>
  <keyword>Supplements</keyword>
  <keyword>Vitamin B3</keyword>
  <keyword>Nicotinamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacinamide</mesh_term>
    <mesh_term>Niacin</mesh_term>
    <mesh_term>Nicotinic Acids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797469
org study id: AAAR8208
nct id: NCT03797469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study seeks to test whether these over-the-counter nutritional supplements have an
      impact on patients' performance during visual field testing.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in 24-2 visual field test
time frame: Up to 20 weeks
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.
measure: Change in Montreal Cognitive Assessment (MoCA) scores
time frame: Up to 20 weeks
description: 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.
arm group label: Nicotinamide and Pyruvate (N&P)
arm group type: Active Comparator
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 group label: Placebo
arm group type: Placebo Comparator
description: This group will receive an equal number of tablets as the N&P group.
intervention type: Dietary Supplement
intervention name: Vitamin B3
description: 3 tablets of 1000 mg each will be administered orally.
arm group label: Nicotinamide and Pyruvate (N&P)
other name: B-3 Nicotinamide
intervention type: Dietary Supplement
intervention name: Pyruvate
description: 2 tablets of 1500 mg each will be administered orally.
arm group label: Nicotinamide and Pyruvate (N&P)
other name: Calcium Pyruvate
intervention type: Dietary Supplement
intervention name: Placebo
description: Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey M Liebmann, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
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.
PMID: 29497468
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.
PMID: 29295624
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.
PMID: 28858158
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.
PMID: 28538117
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.
PMID: 28487632
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.
PMID: 28209901
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Jeffrey Liebmann
investigator title: Professor of Ophthalmology
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Niacinamide
mesh term: Niacin
mesh term: Nicotinic Acids
sharing ipd: No