Blackcurrant seed oil for prevention of atopic allergy
| ISRCTN | ISRCTN14869647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14869647 |
| Protocol serial number | N/A |
| Sponsor | University of Turku (Finland) |
| Funder | Ministry of Agriculture and Forestry (Finland) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Blackcurrant seed oil |
| Primary outcome measure(s) |
Prevalence of atopic dermatitis by the age of 12 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 23/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
