Primary Open-Angle Glaucoma (POAG)NiSPoGNCT07007260
Effect of Niacinamide Supplementation in Glaucoma
A study testing niacinamide supplementation in people with Primary Open-Angle Glaucoma (POAG), run by University of Medicine and Pharmacy Craiova at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma (POAG)
- What is being tested?
- niacinamide supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteRomania
- Study dates
- 20 Feb 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Romania1 site
University of Medicine and Pharmacy of Craiova
Craiova, Dolj, 200349
About this study
Official title: Effect of Niacinamide Supplementation in Primary Open-angle Glaucoma
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.
Read the detailed description
100 subjects with primary open-angle glaucoma will be enrolled from two centres (CMI profesor doctor Liliana Mary Voinea Bucharest Eye Centre and SC Optispecs Med SRL TgJiu Eye Clinic).
Participant Selection P1. Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- 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.
P2. Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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),
- IOP >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 niacinamide/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, postinflammatory, steroid induced, pseudoexfoliative, pigmentary, etc.);
- Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
- 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).
Participants will:
- Take NAM every day for 1 year
- Visit the clinic at 3, 6, and 12 months for check-ups and tests
Outcome Measures M1. Ophthalmological parameters
- Visual field parameters:
- Mean deviation (MD)
- Pattern standard deviation (PSD)
- Optical coherence tomography parameters: peripapillary retinal nerve fiber layer thickness (pRNFL);
- Visually evoked potential parameter: latence of P2 wave when using a flash stimulus.
M2. Quality of life measurement
➔ Glaucoma Quality of Life-15 questionnaire
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Being tested
- niacinamide supplementation
- Keywords
- visual field progression, quality of life
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacinamide supplementationDietary supplement
Patients will take niacinamide supplementation (500mg) every day for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: niacinamide supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
logMAR
Ophthalmological parameters
➔ Visual field parameters: logMAR
Measured: 3, 6 and 12 months from the baseline
Secondary outcomes (1)
QoL
Glaucoma Quality of Life-15 questionnaire responses (Subtirelu, M.S., Nicola, C.A.; Turcu-Stiolica, M.; Turcu-Stiolica, A. Translation and Cultural Adaptation of the Glaucoma Quality of Life-15 Questionnaire to the Romanian Population. Value in Health 2023, Volume 26, Issue 6, S318-S319)
Measured: 3, 6 and 12 months from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start20 Feb 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy Craiova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adina Turcu-Stiolica, University of Medicine and Pharmacy Craiova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007260
- Sponsor's protocol ID
- NiSPoG
- Acronym
- NiSPoG
- Status last verified
- May 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40944166
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Niacinamide Supplementation in Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT07007260
- Acronym / sponsor ID
- NiSPoG / NiSPoG
- Conditions
- Primary Open-Angle Glaucoma (POAG)
- Keywords
- visual field progression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy CraiovaUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
100 subjects with primary open-angle glaucoma will be enrolled from two centres (CMI profesor doctor Liliana Mary Voinea Bucharest Eye Centre and SC Optispecs Med SRL TgJiu Eye Clinic).
Participant Selection P1. Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- 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.
P2. Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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),
- IOP >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 niacinamide/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, postinflammatory, steroid induced, pseudoexfoliative, pigmentary, etc.);
- Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
- 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).
Participants will:
- Take NAM every day for 1 year
- Visit the clinic at 3, 6, and 12 months for check-ups and tests
Outcome Measures M1. Ophthalmological parameters
- Visual field parameters:
- Mean deviation (MD)
- Pattern standard deviation (PSD)
- Optical coherence tomography parameters: peripapillary retinal nerve fiber layer thickness (pRNFL);
- Visually evoked potential parameter: latence of P2 wave when using a flash stimulus.
M2. Quality of life measurement
➔ Glaucoma Quality of Life-15 questionnaire
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Primary Open-angle Glaucoma | Experimental | Dietary Supplement: niacinamide supplementationPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niacinamide supplementationPatients will take niacinamide supplementation (500mg) every day for 1 year | Dietary supplement | Patients with Primary Open-angle Glaucoma |
Primary outcome
logMAR
Time frame: 3, 6 and 12 months from the baseline
Ophthalmological parameters ➔ Visual field parameters: logMAR
1 secondary outcome
QoL
Time frame: 3, 6 and 12 months from the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 40944166Nicola 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.
Related trials for Primary Open-Angle Glaucoma (POAG)
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing niacinamide supplementation in people with Primary Open-Angle Glaucoma (POAG), run by University of Medicine and Pharmacy Craiova at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
logMAR (time frame: 3, 6 and 12 months from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.