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ISRCTN
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ISRCTN98554309
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ClinicalTrials.gov identifier
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Public title
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Optimisation of vitamin A dosing schedules in infancy
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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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Early high-dose vitamin A supplementation of mothers and infants improves vitamin A status and protects against mucosal infections, growth faltering and illness compared to the standard World Health Organisation (WHO) regimen.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Gambia
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Disease/condition/study domain
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Vitamin A deficiency
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Participants - inclusion criteria
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Consenting mothers and new born infants in six villages in the West Kiang region of The Gambia.
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Participants - exclusion criteria
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1. Congenital defects
2. Birthweight under 2200 g
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Anticipated start date
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01/09/2001
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Anticipated end date
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01/10/2004
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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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220
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Interventions
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Early high dose Vitamin A schedule versus standard WHO schedule.
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Primary outcome measure(s)
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1. Vitamin A status in mothers and infants
2. Heliobacter pylori infection in infants
3. Nasopharyngeal pneumococcal carriage in mothers and infants
4. Gut permeability in infants assessed by Dual Pugar Permeability Test (DSPT)
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Secondary outcome measure(s)
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1. Infant growth
2. Infant morbidity
3. Breast milk sodium-potassium ratios
4. Breast-milk oligosaccharides
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17586304
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Contact name
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Prof
Andrew
Prentice
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Address
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MRC International Nutrition Group
London School of Hygiene and Tropical Medicine
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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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Tel
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+44 (0)20 7958 8140
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Fax
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+44 (0)20 7958 8111
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Email
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andrew.prentice@lshtm.ac.uk
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Sponsor
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Medical Research Council (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1N 4AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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corporate@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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30/08/2005
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Last edited
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27/07/2007
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Date ISRCTN assigned
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10/10/2005
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