Nicotinamide and Glaucoma

NCT ID: NCT05916066

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-16

Study Completion Date

2022-04-30

Brief Summary

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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

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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

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy controls

Healthy controls

Group Type OTHER

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Tabletts of 500mg Nicotinamide (B3-vitamin)

Pseudoexfoliative glaucoma

PEXG

Group Type OTHER

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Tabletts of 500mg Nicotinamide (B3-vitamin)

POAG

POAG

Group Type OTHER

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Tabletts of 500mg Nicotinamide (B3-vitamin)

NTG

NTG

Group Type OTHER

Nicotinamide

Intervention Type DIETARY_SUPPLEMENT

Tabletts of 500mg Nicotinamide (B3-vitamin)

Interventions

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Nicotinamide

Tabletts of 500mg Nicotinamide (B3-vitamin)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Clinical Science, Ophthalmology, Umeå University

Umeå, Västerbotten County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NAMG2021

Identifier Type: -

Identifier Source: org_study_id

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