Data

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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Subjects

Ophthalmology |

Source Study

Trial acronym

Not available

Trial ID

ACTRN12617000809336

Purpose

Treatment

Phase

Phase 4

Funding

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?

No

 

Population

Sample Size    60

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Glaucoma

Condition code    Eye

Intervention

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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Comparison

Control group Placebo

Placebo control (sugar pill) will be given to participants

Outcomes

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 anzctr.org.au