Salmon in Pregnancy Study (SiPS)
Recruitment status was Active, not recruiting
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Purpose
The number of infants and children with allergic disease (dermatitis, allergies, asthma) has increased over the last several decades. This may be related to changes in diet. It is now thought that children become sensitised to allergens very early in life maybe even before they are born. Some studies show that a high omega-3 fat intake by mothers decreases risk of sensitisation in their babies. There is a biological mechanism to explain this. Omega-3 fats are found in oily fish like salmon. In the UK pregnant women are recommended to eat oily fish twice per week. However, consumption of oily fish is known to be low in pregnant women in the UK. This study sets out to identify the effects of increasing salmon intake in pregnant women. The hypothesis being investigated is that : increased consumption of oily fish during pregnancy by women at risk of having offspring who will develop atopy will increase their omega-3 fat and antioxidant status and that of their developing baby and will ameliorate the development of atopic markers and manifestations in the infants.
| Condition | Intervention |
|---|---|
|
Dermatitis Allergies Asthma |
Dietary Supplement: Oily fish consumption Other: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effects of Oily Fish in Pregnancy on Markers and Manifestations of Allergic Diseases in Infants at Risk of Atopy |
- Omega-3 fatty acid status in maternal and umbilical cord plasma [ Time Frame: Weeks 20, 34 and 38 of pregnancy and at birth (in cord) ] [ Designated as safety issue: No ]
- Antioxidant status in maternal and umbilical cord blood [ Time Frame: Weeks 20, 34 and 38 of pregnancy and at birth (in cord) ] [ Designated as safety issue: No ]
- Allergic sensitisation of infants [ Time Frame: 6 months of age ] [ Designated as safety issue: No ]
| Enrollment: | 124 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control
No change in diet
|
Other: Control
No change to habitual diet from week 20 of pregnancy until giving birth
|
|
Active Comparator: Oily fish
Two portions of salmon per week from week 20 of pregnancy until giving birth
|
Dietary Supplement: Oily fish consumption
Two portions of salmon per week from week 20 of pregnancy until giving birth
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pregnant women before 19 weeks gestation, with healthy uncomplicated singleton pregnancies, but whose babies are at risk of atopy (i.e. one or more first degree relatives affected).
- Not habitual consumers of oily fish (< 2 portions of oily fish per month excluding tinned tuna).
- Not using fish oil supplements (currently or in the last 3 months)
- Age 18-40 y.
Exclusion Criteria:
- Habitual consumer of oily fish (> 2 portions of oily fish per month excluding tinned tuna).
- Use of fish oil supplements within the previous 3 months.
- Not willing for essential identifiable information being stored for tracking purposes.
- Participation in another research study.
- Known diabetic and/or other auto-immune disease, e.g. SLE, MS, Thyroid Disease.
- Adults with learning disabilities.
- Adults who have a terminal illness.
- Adults with mental health problems.
Contacts and Locations More Information
No publications provided by University Hospital Southampton NHS Foundation Trust.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Christine McGrath, Southampton University Hospitals Trust |
| ClinicalTrials.gov Identifier: | NCT00801502 History of Changes |
| Other Study ID Numbers: | RHMNUT0044 |
| Study First Received: | December 2, 2008 |
| Last Updated: | December 2, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University Hospital Southampton NHS Foundation Trust.:
|
Omega-3 Oily fish Antioxidant Selenium |
Atopic disease Pregnancy Nutrient status |
Additional relevant MeSH terms:
|
Asthma Dermatitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013