Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Blackcurrant seed oil for prevention of atopic allergy: a double-blind placebo-controlled clinical trial
Acronym
Study hypothesis
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.
Ethics approval
Ethical Committee of the Hospital District of South West Finland approved on the 24th August 2003
Study design
Double-blind placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Atopic dermatitis
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Blackcurrant seed oil
Primary outcome measures
Prevalence of atopic dermatitis by the age of 12 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
12/05/2004
Overall trial end date
23/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Mothers during 8th to the 16th weeks of pregnancy
2. Aged between 19 - 43 years of age
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
294
Participant exclusion criteria
1. Premature delivery
2. Need for neonatal intensive care
Recruitment start date
12/05/2004
Recruitment end date
23/01/2008
Locations
Countries of recruitment
Finland
Trial participating centre
Department of Clinical Allergology
Turku
20100
Finland
Sponsor information
Organisation
University of Turku (Finland)
Sponsor details
Department of Food Chemistry
Turun yliopisto
Turku
20014
Finland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Agriculture and Forestry (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20545710
Publication citations
-
Results
Linnamaa P, Savolainen J, Koulu L, Tuomasjukka S, Kallio H, Yang B, Vahlberg T, Tahvonen R, Blackcurrant seed oil for prevention of atopic dermatitis in newborns: a randomized, double-blind, placebo-controlled trial., Clin. Exp. Allergy, 2010, 40, 8, 1247-1255, doi: 10.1111/j.1365-2222.2010.03540.x.