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ISRCTN
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ISRCTN14869647
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ClinicalTrials.gov identifier
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Public title
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Blackcurrant seed oil for prevention of atopic allergy
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Scientific title
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Blackcurrant seed oil for prevention of atopic allergy: a double-blind placebo-controlled clinical trial
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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 supplementation with blackcurrant seed oil increases the intake of n-3 and n-6 essential fatty acids, especially the intake of gamma-linolenic acid and stearidonic acid and reduces the risk of atopic allergy in infants.
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Lay summary
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Ethics approval
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Ethical Committee of the Hospital District of South West Finland approved on the 24th August 2003
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Study design
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Double-blind placebo-controlled clinical trial
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Atopic dermatitis
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Participants - inclusion criteria
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1. Mothers during 8th to the 16th weeks of pregnancy
2. Aged between 19 - 43 years of age
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Participants - exclusion criteria
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1. Premature delivery
2. Need for neonatal intensive care
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Anticipated start date
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12/05/2004
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Anticipated end date
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23/01/2008
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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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294
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Interventions
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Blackcurrant seed oil was given to pregnant mothers and newborn infants for the first 24 months of life. Control group received olive oil as placebo. The mothers were given capsules, 3 g per day and born children olive oil as liquid 1 ml per day. The dosages were the same as that of the active group.
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Primary outcome measure(s)
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Prevalence of atopic dermatitis by the age of 12 months
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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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Ministry of Agriculture and Forestry (Finland)
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Trial website
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Publications
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Contact name
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Prof
Johannes
Savolainen
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Address
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Department of Clinical Allergology
University of Turku
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City/town
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Turku
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Zip/Postcode
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20100
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Country
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Finland
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Sponsor
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University of Turku (Finland)
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Address
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Department of Food Chemistry
Turun yliopisto
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City/town
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Turku
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Zip/Postcode
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20014
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Country
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Finland
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Sponsor website:
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http://www.utu.fi/en/
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Date applied
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23/09/2009
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Last edited
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19/11/2009
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Date ISRCTN assigned
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19/11/2009
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