Effect of Niacinamide Supplementation in Glaucoma

NCT07007260 | Completed

• 1 other identifier: NiSPoG
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Niacinamide is a chemical derivative of niacin, also known as vitamin B3. Through its complex role in the energetic metabolism, it has been evaluated and proven useful in several neurodegenerative disorders, such as Alzheimer's disease. Its effect in glaucoma, an optic nerve disorder related to a high intraocular pressure, is not well defined, and requires more research. The investigators aim to assess the physiological effects of niacinamide on specific markers (e.g., visual field parameters, retinal nerve fibre layer thickness, electrophysiological markers such as the latency of the P2 wave on Flash visually evoked potentials) and on the quality of life in primary glaucoma patients.

Conditions

Primary Open-Angle Glaucoma (POAG)

Keywords

visual field progression; quality of life

Outcome Measures

Primary Outcomes (1)

• logMAR

  Ophthalmological parameters ➔ Visual field parameters: logMAR

  3, 6 and 12 months from the baseline

Secondary Outcomes (1)

• QoL

  3, 6 and 12 months from the baseline

Study Arms (1)

Patients with Primary Open-angle Glaucoma

EXPERIMENTAL

Patients aged 18 years or older with confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography).

Dietary Supplement: niacinamide supplementation

Interventions

niacinamide supplementation DIETARY_SUPPLEMENT

Patients will take niacinamide supplementation (500mg) every day for 1 year

Patients with Primary Open-angle Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older;
• Confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography); Subject has provided signed and dated written informed consent before admission to the study.
• Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
• Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
• Have performed at least two reliable VFs (SITA-Fast 24-2), with \<33% fixation losses and \<15% false positives
• Those taking NAM already will undergo a 1-month washout period before commencing the study.

You may not qualify if:

• Participants must not be pregnant or breastfeeding women;
• Investigator considers the subject unfit for the study as a result of medical history, physical examination, or screening tests;
• ● VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot with -10dB or less in any eye),
• OP \>35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
• those unwilling to abstain from NAM supplements,
• allergic to NAM/niacin,
• diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma),
• a history of liver disease or stomach ulcers,
• disease that prevents long-term follow-up, neurologic or other non-glaucomatous conditions apart from cataract that may affect the VF
• Patient is diagnosed with primary angle closure glaucoma;
• Patient is diagnosed with secondary glaucoma (e.g. posttraumatic, post inflammatory, steroid induced, pseudo exfoliative, pigmentary, etc.);
• Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
• Participants who are currently on NAM will be asked to stop taking the tablets for a month prior to screening visit.
• Patient is diagnosed with other significant ocular pathologies (advanced cataract, pathologic myopia, corneal ectasias or dystrophies, sever amblyopia, vitreoretinal disease, active ocular inflammation, significant sequelae of ocular inflammation);
• Unreliable ophthalmological investigations and non-compliance with examinations (e.g. high percentage of false negative and false positive errors when examining the visual field).

Sponsors & Collaborators

• University of Medicine and Pharmacy Craiova: lead

Study Sites (1)

University of Medicine and Pharmacy of Craiova

Craiova, Dolj, 200349, Romania

Location

Related Publications (1)

• Nicola CA, Marinescu MC, Firan AM, Tartea G, Naidin MS, Ciuluvica RC, Dimulescu MD, Voicu NM, Mihailescu CM, Meca AD, Bogdan M, Turcu-Stiolica A. Changes in Quality of Life Among Glaucoma Patients Following Six Months of Niacinamide Supplementation. Nutrients. 2025 Aug 27;17(17):2775. doi: 10.3390/nu17172775.

  PMID: 40944166 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: June 5, 2025
• Study Start: February 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-05

Locations

RO (1)