An interventional study of Nicotinamide and Placebo in Glaucoma, sponsored by Umeå University. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Umeå University · Not applicable, Interventional, and Treatment
The Glaucoma Nicotinamide Trial (TGNT) is a prospective, randomized, placebo-controlled double-masked clinical trial composed of two cohorts; The Swedish Glaucoma Nicotinamide Trial (SGNT) and the Vitamin B3 In Glaucoma Study (VBIGS). Patients with open-angle glaucoma (OAG) will be randomized to receive either Nicotinamide or placebo through block randomization stratified by glaucoma subtype with a 1:1 allocation.
The treatment arms that included patients will be randomized into are either Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards or true placebo tablets. A major difference between the SGNT and VBIGS is that in SGNT untreated newly diagnosed glaucoma patients will be included whereas in VBIGS glaucoma patients with intraocular pressure lowering treatment will be included. Also, in SGNT an additional non-blinded arm with healthy subjects will receive Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards. For participants where both eyes are eligible, both will be included.
The primary endpoint is visual field progression change over two years.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 660 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
SGNT:
Inclusion Criteria:
Exclusion Criteria:
VBIGS:
Inclusion Criteria:
Exclusion Criteria:
Participants will receive 750mg nicotinamide tablets 1+1 per day (1.5g) for 6 weeks and after that 2+2 per day (3.0g).
Dietary Supplement: Nicotinamide
Participants will receive 750mg placebo tablets 1+1 per day for 6 weeks and after that 2+2 per day.
Other: Placebo
Study tablets for nicotinamide are produced by Blackmores Ltd.
Study tablets for placebo are produced by Blackmores Ltd.
Visual field progression
Change in rate of progression between the two study arms
Time frame: Two years
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Umeå University