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Dietary Supplement
Nicotinamide + Pyruvate for Open-Angle Glaucoma
Phase 2 & 3
Recruiting
Led By Aakriti G. Shukla, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 87 weeks
Awards & highlights
Study Summary
This trial studies if N&P can help keep eyes healthy when treating glaucoma with standard meds.
Who is the study for?
Adults aged 40-85 with primary open-angle, pseudoexfoliative, or pigmentary glaucoma can join this study. They must be able to consent, have one qualifying eye with specific characteristics if both are eligible, and perform reliable visual field tests. Participants should not be on certain supplements or have had recent incisional glaucoma surgery.Check my eligibility
What is being tested?
The trial is testing whether oral nicotinamide and pyruvate supplements can help maintain eye health in glaucoma patients compared to a placebo. All participants will continue their usual glaucoma medications during the 21-month study period.See study design
What are the potential side effects?
Potential side effects of nicotinamide and pyruvate may include mild gastrointestinal issues like nausea or upset stomach. Since these are dietary supplements, severe side effects are less common but could involve liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 87 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~87 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in retinal nerve fiber and ganglion cell layer thickness
Change in visual field results based on pointwise and global metrics
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide and PyruvateExperimental Treatment1 Intervention
The N&P group will receive nicotinamide and pyruvate for 87 weeks (20 months).
Group II: PlaceboPlacebo Group1 Intervention
The placebo group will receive placebo for 87 weeks (20 months).
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,785 Total Patients Enrolled
7 Trials studying Glaucoma
13,338 Patients Enrolled for Glaucoma
Aakriti G. Shukla, MDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had glaucoma surgery in the last year.I have been diagnosed with dementia, Alzheimer's, or another neurological disease.I have been diagnosed with a significant cataract affecting my vision.I expect to have eye surgery for glaucoma or cataracts soon.I cannot tolerate or take nicotinamide or pyruvate.I had complications from previous cataract surgery.I have a working glaucoma surgery device.I have an eye condition that greatly affects my vision.I have vision issues not related to glaucoma that affect my visual field and OCT imaging.I have a history of liver disease.I have been diagnosed with a specific type of glaucoma.I am willing to stop taking any supplements for the study period.I am between 40 and 85 years old.My eye pressure is 14 mmHg or higher and was once 16 mmHg or more.I am between 40 and 85 years old.If you have had a previous reliable test for your vision (called a 10-2 test), your eye doctor (ophthalmologist) should determine that your vision is better than -15 decibels (dB).
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide and Pyruvate
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this experiment restricted to individuals over 25 years of age?
"This medical trial has a particular age criteria; patients aged between 40 and 85 are eligible to participate. In comparison, there are 22 trials available for participants under 18 years old while 198 studies accommodate those above 65."
Answered by AI
Are there vacancies in this medical experiment for potential participants?
"As evidenced on clinicaltrials.gov, this trial is actively recruiting participants with the date of inception being 15th January 2023 and most recent update 13th January 2023."
Answered by AI
What criteria are needed to become an eligible participant in this trial?
"This medical trial is seeking to enroll up to 188 people between the ages of 40 and 85 who have a diagnosis of glaucoma."
Answered by AI
What is the scope of this research project in terms of participants?
"Affirmative. Clinicaltrials.gov indicates that enrollment is currently open for this clinical trial, which was uploaded on January 15th of 2023 and updated on the 13th of the same month. The study requires 188 participants to be recruited from two different centres."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
ColumbiaDoctors Ophthalmology - 880 Third Avenue
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