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ISRCTN
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ISRCTN31173864
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ClinicalTrials.gov identifier
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Public title
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The impact of micronutrient supplementation on the health of Zambian adults with particular emphasis on intestinal infection
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Scientific title
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Integrity of small intestinal antimicrobial defence in relation to micronutrients in Zambian adults
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Acronym
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N/A
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Serial number at source
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067948
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Study hypothesis
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To determine if a multiple micronutrient supplement boosts intestinal innate immunity in adults living in an urban environment in Africa.
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Lay summary
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Ethics approval
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Obtained from two ethics committees:
1. University of Zambia Research Ethics Committee
2. London School of Hygiene and Tropical Medicine Research Ethics 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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Zambia
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Disease/condition/study domain
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Intestinal innate immunity
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Participants - inclusion criteria
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All adults (over 18 years of age, either sex) resident within a defined geographical area of Misisi compound, Lusaka, Zambia, have been invited to participate.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/06/2003
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Anticipated end date
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01/01/2007
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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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500
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Interventions
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Randomised, placebo-controlled trial of solid tablet formulation of 15 micronutrients, administered daily, with cross-over after two years.
The anticipated end date of this trial has been shortened to 1st January 2007, the previous anticipated end date was 31/08/2007.
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Primary outcome measure(s)
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1. Frequency of diarrhoeal disease
2. CD4 count in human immunodeficiency virus (HIV) seropositive participants
3. Expression of antimicrobial peptides in small intestinal tissue and secretions
4. Change in micronutrient status
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 067948)
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Trial website
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18842788
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20604937
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Contact name
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Dr
Paul
Kelly
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Address
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Tropical Gastroenterology & Nutrition Group
University of Zambia School of Medicine
Nationalist Road
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City/town
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Lusaka
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Zip/Postcode
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-
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Country
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Zambia
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Tel
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+260 1 252269
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Fax
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+260 1 252269
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Email
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m.p.kelly@qmul.ac.uk
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Sponsor
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London School of Hygiene and Tropical Medicine (UK)
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Address
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Research Grants and Contracts Office
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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Tel
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+44 (0)20 7827 2678
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Fax
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+44 (0)20 7927 5636
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Email
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Penny.Ireland@lshtm.ac.uk
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Sponsor website:
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http://www.lshtm.ac.uk
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Date applied
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22/07/2005
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Last edited
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02/12/2010
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Date ISRCTN assigned
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22/07/2005
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