Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Miss Hannah Bartlett
ORCID ID
Contact details
Neuroscience Research Institute
School of Life and Health Sciences
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
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bartlehe@aston.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial
Acronym
Study hypothesis
Age-related macular degeneration is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants in the prevention and treatment of this eye disease.
Ethics approval
Approved by the Aston University Human Sciences Ethical Committee.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Age-related macular degeneration
Intervention
The study formulation contains:
Lutein 10 mg
Vitamin C 250 mg
Vitamin E 34 mg
Vitamin A 750 µg
Zinc 10 mg
Copper 0.5 mg
Intervention type
Supplement
Phase
Not Specified
Drug names
Lutein based nutritional supplement
Primary outcome measure
1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts
2. Contrast sensitivity (CS) measured using a Pelli-Robson chart
3. Colour vision measured using the PV-16 quantitative colour vision test
4. Macular Mapping (MM) test
5. Eger Macular Stressometer (EMS) used to assess glare recovery
6. Fundus photographs of the macular will be assessed using colour and edge analysis software
Data collection will take place at baseline, nine, and 18 months.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2003
Overall trial end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Have to provide written informed consent
2. Have to be available for three visits to Aston University
3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
159
Participant exclusion criteria
Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.
Recruitment start date
01/07/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neuroscience Research Institute
Birmingham
B4 7ET
United Kingdom
Sponsor information
Organisation
Aston University (UK)
Sponsor details
Neurosciences Research Institute
School of Life and Health Sciences
Aston Triangle
Birmingham
B4 7ET
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
College of Optometrists (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
Basic results (scientific)
Publication list
2003 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/14594455
2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18294739
Publication citations
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Protocol
Bartlett H, Eperjesi F, A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674]., Nutr J, 2003, 2, 12, doi: 10.1186/1475-2891-2-12.