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Salmon in Pregnancy Study (SiPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital Southampton NHS Foundation Trust..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Southampton
Information provided by:
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT00801502
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation 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
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
Criteria

Inclusion Criteria:

  1. 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).
  2. Not habitual consumers of oily fish (< 2 portions of oily fish per month excluding tinned tuna).
  3. Not using fish oil supplements (currently or in the last 3 months)
  4. Age 18-40 y.

Exclusion Criteria:

  1. Habitual consumer of oily fish (> 2 portions of oily fish per month excluding tinned tuna).
  2. Use of fish oil supplements within the previous 3 months.
  3. Not willing for essential identifiable information being stored for tracking purposes.
  4. Participation in another research study.
  5. Known diabetic and/or other auto-immune disease, e.g. SLE, MS, Thyroid Disease.
  6. Adults with learning disabilities.
  7. Adults who have a terminal illness.
  8. Adults with mental health problems.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Hospital Southampton NHS Foundation Trust.
University of Southampton
  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:
Dermatitis
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014