ACTIVE_NOT_RECRUITING

Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N\&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma. A total of up to 188 participants will be enrolled and randomized 1:1 to receive N\&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).

Official Title

Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study

Quick Facts

Study Start:2023-03-14
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05695027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Aakriti G. Shukla, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Stanford University Department of Ophthalmology
Palo Alto, California, 94303
United States
ColumbiaDoctors Ophthalmology - 880 Third Avenue
New York, New York, 10022
United States
Columbia University Irving Medical Center - 622 W 168th St
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Aakriti G. Shukla, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • nutritional supplement
  • nicotinamide
  • pyruvate

Additional Relevant MeSH Terms

  • Primary Open Angle Glaucoma