Salmon in Pregnancy Study - Full Text View

Sponsors and Collaborators:	Southampton University Hospitals NHS Trust University of Southampton
Information provided by:	Southampton University Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00801502

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

MedlinePlus related topics: Allergy Antioxidants Asthma Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment
Official Title:	The Effects of Oily Fish in Pregnancy on Markers and Manifestations of Allergic Diseases in Infants at Risk of Atopy

Further study details as provided by Southampton University Hospitals NHS Trust:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Oily fish: Active Comparator 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

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Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801502

Locations

United Kingdom
University of Southampton
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Southampton University Hospitals NHS Trust

University of Southampton

More Information

No publications provided

Responsible Party:	Southampton University Hospitals Trust ( Christine McGrath )
Study ID Numbers:	RHMNUT0044
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801502 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Southampton University Hospitals NHS Trust:

Omega-3
Oily fish
Antioxidant
Selenium

Atopic disease
Pregnancy
Nutrient status

Study placed in the following topic categories:

Selenium
Hypersensitivity
Antioxidants

Skin Diseases
Asthma
Dermatitis

Additional relevant MeSH terms:

Skin Diseases
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009