Condition category
Skin and Connective Tissue Diseases
Date applied
23/09/2009
Date assigned
19/11/2009
Last edited
22/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Johannes Savolainen

ORCID ID

Contact details

Department of Clinical Allergology
University of Turku
Turku
20100
Finland

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

http://www.utu.fi/en/

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

  1. 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.

Additional files

Editorial Notes