The Effect of Vitamin B3 Supplementation in Glaucoma - A Prospective Study on the Effect of Nicotinamide Supplementation on Ocul

The University of Melbourne

Dataset description

Dataset for a prospective crossover clinical trial of Vitamin B3 (nicotinamide) supplementation in glaucoma (2017-2019). It includes data for adults diagnosed and treated for glaucoma at the time they were enrolled in the study.
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Ophthalmology |

Source Study

Trial acronym

Not available

Trial ID





Phase 4


Other,Centre for Eye Research Australia

Scientific enquiries

Prof Jonathan Crowston

Brief Summary

This project aims to translate into the clinic a recently published study, demonstrating the protective role of vitamin B3 supplements (nicotinamide) in a mouse model of glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the short-term effect of taking nicotinamide supplements on the eye’s structure and function compared to placebo. Primary aims of this study include: 1) determining whether nicotinamide supplements in part ....
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Key Inclusion Criteria

- Diagnosis of primary open angle glaucoma by an ophthalmologist - Recent (last 6 months), reliable visual field with mean defect equal to or better than -6 dB

Key Exclusion Criteria

- those who are currently or intending to be pregnant/breastfeeding during the study - those unwilling to abstain from other vitamin B supplements during the study period - history of severe allergies or allergic reaction to nicotinamide or niacin - those diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma) - those with a history of liver disease - those who cannot commit to the follow-up visits which occur at 6-weekly intervals over 24 weeks - those who ca ....
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Can healthy volunteers participate?




Sample Size    60

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Glaucoma

Condition code    Eye


Intervention code Treatment: Drugs

International Nonproprietary Name (INN): nicotinamide Intervention: daily nicotinamide supplementation for 12 weeks Dose: accelerated dose from 1.5 grams daily for 6 weeks to 3 grams daily for 6 weeks Mode of administration: oral tablet Study design: 2 participant groups with cross-over study design. Participants are randomly assigned to receive either nicotinamide or placebo for 12 weeks, followed by a cross-over (i.e. those on nicotinamide first will switch to placebo and those on placebo firs ....
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Control group Placebo

Placebo control (sugar pill) will be given to participants


Outcome: Short-term changes in retinal function after intervention, specifically visual field sensitivity assessed using perimetry (visual field machine)
Timepoint: 12 weeks after commencement of intervention

Outcome: Short-term changes in retinal function after intervention, specifically changes to the photopic (light-adapted) electroretinogram (ERG). As nicotinamide leads to NAD+ repletion, which can drive energy repletion in the cells of the retina, the ERG can be affected in different ways. Specific parameters include amplitude and timing changes to the a-wave (photoreceptor), b-wave (bipolar cell) and photopic negative response (PhNR, retinal ganglion cell).
Timepoint: 12 ....

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The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see