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ISRCTN
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ISRCTN55089134
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ClinicalTrials.gov identifier
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Public title
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The effect of the dietary antioxidant supplements lutein and zeaxanthin on retinal macular pigment optical density
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Scientific title
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Macular pigment response to supplemental lutein and zeaxanthin: a twin heritability study
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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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Dietary antioxidant supplements have been shown to have a beneficial effect on the clinical course of age-related macular degeneration (AMD), which is the commonest cause of blindness in the developed world. Of the various antioxidants, lutein (L) and zeaxanthin (Z) are of particular interest because of their biochemical, optical and anatomic properties.
The aim is to assess the effect of a high-dose L and Z supplement on the concentration of these nutrients at the target tissue (the macula) in a large group of healthy monozygotic and dizygotic twins and to determine the heritability of MP augmentation/change in response to supplementation.
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Lay summary
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Lay summary under review 1
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Ethics approval
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St Thomas' Hospital Research Ethics Committee , 25 June 2002, ref: EC02/102
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Study design
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Interventional non-randomised non-placebo controlled supplement single centre study
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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 (AMD)
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Participants - inclusion criteria
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1. Healthy female volunteers, aged 16-50
2. Twin pairs enrolled on TwinsUK adult registry held at St Thomas’ Hospital London (aim to recruit 80 monozygotic and 80 dizygotic pairs)
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Participants - exclusion criteria
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1. Ocular pathology
2. Gastrointestinal disease
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Anticipated start date
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07/03/2004
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Anticipated end date
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15/08/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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322
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Interventions
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All participants asked to take daily macular pigment supplement with food, “Macuvite” (Springfield®), consisting of 18mg lutein (in its free form) and 2.4mg zeaxanthin (derived from marigold flowers and microalgae) for 6 months, whilst continuing normal diet. Supplement taken in pill form. No control group.
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Primary outcome measure(s)
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Heritability of response to macular pigment supplement, measured using:
1. Reverse phase high performance liquid chromatography to measure serum carotenoid levels at baseline and three months
2. Heterochromatic flicker photometry (HFP) and 2-wavelength fundus autofluorescence (AF) to measure macular pigment optical density (MPOD) at baseline, three months and six months
3. Maximum likelihood modelling using Mx programme to estimate heritability of MP response to supplementation
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Secondary outcome measure(s)
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1. Relationship between central retinal thickness and MPOD, measured using:
1.1. Optical coherence tomography to measure retinal thickness
1.2. HFP and AF to measure MPOD
2. Heritability of MP in the healthy eye, measured using:
2.1. HFP and AF to measure MPOD
2.2. Maximum likelihood modelling using Mx programme to estimate heritability of MPOD
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Sources of funding
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Wellcome Trust (UK) ref: 065730
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Trial website
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Publications
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Contact name
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Prof
Clare
Gilbert
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Address
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London School Of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Sponsor
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Guy's & St Thomas' NHS Trust (UK)
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Address
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Research & Development Office
St Thomas' Hospital
Westminster Bridge Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 7188
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Email
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philippa.sacre@kcl.ac.uk
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Sponsor website:
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http://www.guysandstthomas.nhs.uk/
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Date applied
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14/12/2011
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Last edited
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10/02/2012
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Date ISRCTN assigned
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10/02/2012
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