Nicotinamide and Glaucoma
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedStudy Start
First participant enrolled
October 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedJune 23, 2023
June 1, 2023
7 months
October 4, 2021
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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?
Two weeks
Secondary Outcomes (1)
Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
Two weeks
Study Arms (4)
Healthy controls
OTHERHealthy controls
Pseudoexfoliative glaucoma
OTHERPEXG
POAG
OTHERPOAG
NTG
OTHERNTG
Interventions
Tabletts of 500mg Nicotinamide (B3-vitamin)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Department of Clinical Science, Ophthalmology, Umeå University
Umeå, Västerbotten County, 90187, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2021
First Posted
June 23, 2023
Study Start
October 16, 2021
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
June 23, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share