GlaucomaNCT05916066
Nicotinamide and Glaucoma
A study testing Nicotinamide in people with Glaucoma, run by Umeå University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Nicotinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2021to 30 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -A normal visual field and optic nerve, age > 18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Science, Ophthalmology, Umeå University
Umeå, Västerbotten County, 90187
About this study
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Nicotinamide
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDietary supplement
Tabletts of 500mg Nicotinamide (B3-vitamin)
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Healthy controls Receives: Dietary Supplement: Nicotinamide |
| Pseudoexfoliative glaucoma | Other | PEXG Receives: Dietary Supplement: Nicotinamide |
| POAG | Other | POAG Receives: Dietary Supplement: Nicotinamide |
| NTG | Other | NTG Receives: Dietary Supplement: Nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Two weeks
Secondary outcomes (1)
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?
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start16 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916066
- Sponsor's protocol ID
- NAMG2021
- Status last verified
- Jun 2023
- First submitted
- 4 Oct 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide and Glaucoma
- ClinicalTrials.gov ID
- NCT05916066
- Acronym / sponsor ID
- NAMG2021
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 23 Jun 2023 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Dietary Supplement: NicotinamideHealthy controls |
| Pseudoexfoliative glaucoma | Other | Dietary Supplement: NicotinamidePEXG |
| POAG | Other | Dietary Supplement: NicotinamidePOAG |
| NTG | Other | Dietary Supplement: NicotinamideNTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- -A normal visual field and optic nerve, age > 18 years.
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| NicotinamideTabletts of 500mg Nicotinamide (B3-vitamin) | Dietary supplement | Healthy controls, NTG, POAG, Pseudoexfoliative glaucoma |
Primary outcome
Plasma level of NAM before and after NAM treatment in all groups
Time frame: Two weeks
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?
1 secondary outcome
Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
Time frame: Two weeks
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 23 Jun 2023.
- Individual participant dataSharing planned: No
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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 Nicotinamide in people with Glaucoma, run by Umeå University at 1 site in Sweden.
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 5 inclusion and 8 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 23 Jun 2023. 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 Sweden. 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?
Plasma level of NAM before and after NAM treatment in all groups (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023; AzTrials last refreshed its copy on 2 Nov 2026.