Nicotinamide and Glaucoma
- Conditions
- Glaucoma
- Interventions
- Dietary Supplement: Nicotinamide
- Registration Number
- NCT05916066
- Lead Sponsor
- Umeå University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Healthy controls Nicotinamide Healthy controls Pseudoexfoliative glaucoma Nicotinamide PEXG NTG Nicotinamide NTG POAG Nicotinamide POAG
- Primary Outcome Measures
Name Time Method Plasma level of NAM before and after NAM treatment in all groups 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?
- Secondary Outcome Measures
Name Time Method Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus Two weeks Will a short-term treatment with NAM influence the retinal vasculature measured with OCTA?
Trial Locations
- Locations (1)
Department of Clinical Science, Ophthalmology, Umeå University
🇸🇪Umeå, Västerbotten, Sweden