Blackcurrant seed oil for prevention of atopic allergy
| ISRCTN | ISRCTN14869647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14869647 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/09/2009
- Registration date
- 19/11/2009
- Last edited
- 22/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Johannes Savolainen
Scientific
Scientific
Department of Clinical Allergology
University of Turku
Turku
20100
Finland
Study information
| Study design | Double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Blackcurrant seed oil for prevention of atopic allergy: a double-blind placebo-controlled clinical trial |
| Study objectives | 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(s) | Ethical Committee of the Hospital District of South West Finland approved on the 24th August 2003 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Blackcurrant seed oil |
| Primary outcome measure | Prevalence of atopic dermatitis by the age of 12 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 12/05/2004 |
| Completion date | 23/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 294 |
| Key inclusion criteria | 1. Mothers during 8th to the 16th weeks of pregnancy 2. Aged between 19 - 43 years of age |
| Key exclusion criteria | 1. Premature delivery 2. Need for neonatal intensive care |
| Date of first enrolment | 12/05/2004 |
| Date of final enrolment | 23/01/2008 |
Locations
Countries of recruitment
- Finland
Study participating centre
Department of Clinical Allergology
Turku
20100
Finland
20100
Finland
Sponsor information
University of Turku (Finland)
University/education
University/education
Department of Food Chemistry
Turun yliopisto
Turku
20014
Finland
| Website | http://www.utu.fi/en/ |
|---|---|
"ROR" |
https://ror.org/05vghhr25 |
Funders
Funder type
Government
Ministry of Agriculture and Forestry (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | Yes | No |
