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ISRCTN
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ISRCTN78467674
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ClinicalTrials.gov identifier
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Public title
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The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Approved by the Aston University Human Sciences Ethical Committee.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Age-related macular degeneration
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/07/2003
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Anticipated end date
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01/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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159
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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College of Optometrists (UK)
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Trial website
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http://www.aston.ac.uk/downloads/lhs/website_protocol.pdf
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Publications
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Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14594455
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Contact name
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Miss
Hannah
Bartlett
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Address
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Neuroscience Research Institute
School of Life and Health Sciences
Aston University
Aston Triangle
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City/town
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Birmingham
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Zip/Postcode
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B4 7ET
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Country
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United Kingdom
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Email
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bartlehe@aston.ac.uk
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Sponsor
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Aston University (UK)
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Address
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Neurosciences Research Institute
School of Life and Health Sciences
Aston Triangle
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City/town
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Birmingham
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Zip/Postcode
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B4 7ET
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Country
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United Kingdom
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Sponsor website:
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http://www.aston.ac.uk/
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Date applied
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20/06/2003
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Last edited
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05/09/2007
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Date ISRCTN assigned
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11/09/2003
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