Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of nutritional supplementation on retinal function: a randomised controlled trial
Acronym
Study hypothesis
Nutritional supplementation may have an effect on retinal function. A randomised controlled trial comparing those taking a nutritional supplement with a control group.
Ethics approval
Aston University Ethics Committee, 01/10/2008, ref: REG/06/288[1]
Study design
Single-blind single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Age-related macular disease
Intervention
Nutritional supplement (oral) containing vitamin C 150 mg, vitamin E 15 mg, lutein 12 mg, zeaxanthin 0.6 mg, copper 400 µg, zinc 20 mg, omega-3 fatty acids 1,080 mg per day for 80 weeks.
Control group: no interventions (no placebo used)
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin C, vitamin E, lutein, zeaxanthin, copper, zinc, omega-3 fatty acids
Primary outcome measures
Multifocal electroretinogram amplitudes and latencies, assessed every 20 weeks for a period of 80 weeks
Secondary outcome measures
Macular pigment optical density, assessed every 20 weeks for a period of 80 weeks
Overall trial start date
01/01/2009
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All participants (both males and females) must be aged 18 - 80 years.
1. For early age-related maculopathy (ARM) group in either eye or both eyes:
1.1. Drusen
1.2. Drusen with hyperpigmentation
1.3. Drusen with hypopigmentation
2. For early age-related maculopathy (ARM) group and normal group in either eye or both eyes:
2.1. Best corrected visual acuity of 6/9 or better
2.2. Good central fixation (necessary for the multifocal electroretinogram [mfERG])
2.3. Clear optical media
2.4. No signs of other retinal or optic nerve disease
2.5. Good general health
2.6. No medication that affects the retina
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Moderate to dense lens opacities
2. Intraocular lens
3. Corneal opacities
4. Glaucoma or ocular hypertension
5. Previous history of intraocular inflammation (e.g. uveitis)
6. Previous history of retinal detachment
7. Retinal disease
8. Previous retinal laser
9. Diabetes
10. Systemic hypertension
11. History of ocular trauma
12. Neurological disease
13. Advanced age-related macular disease (choroidal neovascularisation [CNV] or geographic atrophy [GA]) in the studied eye
14. Drugs causing retinal toxicity (chloroquine, cisplatin, oxazepam, vigabatrin)
15. Previous ocular surgery (excluding laser-assisted in situ keratomileusis [LASIK]/endothelial keratoplasty [EK])
16. Epilepsy
Recruitment start date
01/01/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aston University
Birmingham
B4 7ET
United Kingdom
Funders
Funder type
Industry
Funder name
Bausch and Lomb (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary