Nicotinamide and Glaucoma

The investigators will include different subgroups of open-angle glaucoma and healthy controls. The participants will attend two visits with two weeks apart. At each visit the participants will have blood drawn and will undergo OCT examination. In between the two visits, participants will receive a treatment of Nicotinamide 1,5g/day for one week and 3.0g/day for the second week.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Dietary supplement: Nicotinamide

Detailed Description

The investigators plan to recruit four groups, each containing 30 subjects: 1) pseudoexfoliative glaucoma, 2) High tension open-angle glaucoma, 3) Normal tension glaucoma 4) Age-matched controls. Those enrolled will undergo two visits including an ophthalmic exam, blood sampling, and at the first visit, distribution of nicotinamide tablets. We plan to recruit participants amongst glaucoma patients already followed at the Eye Clinic at Umeå University Hospital. Furthermore, age-matched controls will be recruited through lists from the population register at Statistics Sweden. Before enrolling any subject, they will receive both oral and written information as well as sign a consent form. Furthermore, they will be evaluated to make sure that they fulfill the inclusion- and exclusion criteria prior to inclusion.

The ophthalmic exam includes measurement of IOP, perimetry, and OCT/A. Between visits, the participants will receive 1,5 grams of NAM per day the first week and 3 grams per day the second week. The blood drawn will initially be sent to Biobanken Norr for storage. Samples will then be sent to the Swedish Metabolomics Centre, Umeå University and Department of Medical Biochemistry and Biophysics, Karolinska University for analysis using high-resolution mass spectrometry.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90187
      • Department of Clinical Science, Ophthalmology, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for glaucoma patients:

• Manifest glaucoma (PEXG, HTG, NTG) in one or two eyes,
• age > 18 years,
• replicable visual field defects that cannot be explained by any other disease or insult,
• suspect/anomalous optic nerve head or abnormalities in the retinal nerve fiber layer.

Inclusion criteria for age-matched controls:

-A normal visual field and optic nerve, age > 18 years.

Exclusion criteria for all:

• Any disease affecting retinal function (such as more than mild macular degeneration or diabetic retinopathy), neurological or other non-glaucomatous conditions that may affect the visual field,
• inability to perform a perimetric exam,
• resistance in quitting intake of multivitamins or B-vitamins,
• allergy to NAM or niacin, previous eye surgery involving the central retina,
• pregnant or breast-feeding women,
• fertile women not using reliable contraception,
• diagnosis of cancer in the last five years (not including treated squamous cell carcinoma), anamnesis of liver-disease or peptic ulcer,
• not able to speak and understand either Swedish or English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy controls	Dietary supplement: Nicotinamide; Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: Pseudoexfoliative glaucoma; PEXG	Dietary supplement: Nicotinamide; Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: POAG	Dietary supplement: Nicotinamide; Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: NTG	Dietary supplement: Nicotinamide; Tabletts of 500mg Nicotinamide (B3-vitamin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma level of NAM before and after NAM treatment in all groups	Are NAM levels in plasma lower in patients with glaucoma compared to healthy controls and will a short-term treatment with NAM raise the plasma concentration of NAM?	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus	Will a short-term treatment with NAM influence the retinal vasculature measured with OCTA?	Two weeks

Collaborators and Investigators

• Sponsor: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: NAMG2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No