Not available
ACTRN12617000809336
Treatment
Phase 4
Other,Centre for Eye Research Australia
Prof Jonathan Crowston
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 .... Read more
- 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
- 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 .... Read more
No
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 .... Read more
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 .... Read more