Salmon in Pregnancy Study

NCT00801502 | Completed DMC

• 1 other identifier: RHMNUT0044
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatitis; Allergies; Asthma

Keywords

Omega-3; Oily fish; Antioxidant; Selenium; Atopic disease; Pregnancy; Nutrient status

Outcome Measures

Primary Outcomes (1)

• Omega-3 fatty acid status in maternal and umbilical cord plasma

  Weeks 20, 34 and 38 of pregnancy and at birth (in cord)

Secondary Outcomes (2)

• Antioxidant status in maternal and umbilical cord blood

  Weeks 20, 34 and 38 of pregnancy and at birth (in cord)

• Allergic sensitisation of infants

  6 months of age

Study Arms (2)

Control

OTHER

No change in diet

Other: Control

Oily fish

ACTIVE COMPARATOR

Two portions of salmon per week from week 20 of pregnancy until giving birth

Dietary Supplement: Oily fish consumption

Interventions

Oily fish consumption DIETARY_SUPPLEMENT

Two portions of salmon per week from week 20 of pregnancy until giving birth

Oily fish

Control OTHER

No change to habitual diet from week 20 of pregnancy until giving birth

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator

Study Sites (1)

University of Southampton

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (10)

• Garcia-Rodriguez CE, Helmersson-Karlqvist J, Mesa MD, Miles EA, Noakes PS, Vlachava M, Kremmyda LS, Diaper ND, Godfrey KM, Calder PC, Gil A, Basu S. Does increased intake of salmon increase markers of oxidative stress in pregnant women? The salmon in pregnancy study. Antioxid Redox Signal. 2011 Dec 1;15(11):2819-23. doi: 10.1089/ars.2011.4108. Epub 2011 Jul 22.

  PMID: 21689025 BACKGROUND

• Miles EA, Noakes PS, Kremmyda LS, Vlachava M, Diaper ND, Rosenlund G, Urwin H, Yaqoob P, Rossary A, Farges MC, Vasson MP, Liaset B, Froyland L, Helmersson J, Basu S, Garcia E, Olza J, Mesa MD, Aguilera CM, Gil A, Robinson SM, Inskip HM, Godfrey KM, Calder PC. The Salmon in Pregnancy Study: study design, subject characteristics, maternal fish and marine n-3 fatty acid intake, and marine n-3 fatty acid status in maternal and umbilical cord blood. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1986S-1992S. doi: 10.3945/ajcn.110.001636. Epub 2011 Aug 17.

  PMID: 21849598 BACKGROUND

• van den Elsen LW, Noakes PS, van der Maarel MA, Kremmyda LS, Vlachava M, Diaper ND, Miles EA, Eussen SR, Garssen J, Willemsen LE, Wilson SJ, Godfrey KM, Calder PC. Salmon consumption by pregnant women reduces ex vivo umbilical cord endothelial cell activation. Am J Clin Nutr. 2011 Dec;94(6):1418-25. doi: 10.3945/ajcn.111.016592. Epub 2011 Oct 19.

  PMID: 22011457 BACKGROUND

• Helmersson-Karlqvist J, Miles EA, Vlachava M, Kremmyda LS, Noakes PS, Diaper ND, Godfrey KM, Calder PC, Basu S. Enhanced prostaglandin F2alpha formation in human pregnancy and the effect of increased oily fish intake: results from the Salmon in Pregnancy Study. Prostaglandins Leukot Essent Fatty Acids. 2012 Jan-Feb;86(1-2):35-8. doi: 10.1016/j.plefa.2011.10.008. Epub 2011 Nov 1.

  PMID: 22047909 BACKGROUND

• Noakes PS, Vlachava M, Kremmyda LS, Diaper ND, Miles EA, Erlewyn-Lajeunesse M, Williams AP, Godfrey KM, Calder PC. Increased intake of oily fish in pregnancy: effects on neonatal immune responses and on clinical outcomes in infants at 6 mo. Am J Clin Nutr. 2012 Feb;95(2):395-404. doi: 10.3945/ajcn.111.022954. Epub 2012 Jan 4.

  PMID: 22218160 BACKGROUND

• Garcia-Rodriguez CE, Mesa MD, Olza J, Vlachava M, Kremmyda LS, Diaper ND, Noakes PS, Miles EA, Ramirez-Tortosa MC, Liaset B, Froyland L, Rossary A, Farges MC, Vasson MP, Aguilera CM, Helmersson-Karlqvist J, Godfrey KM, Calder PC, Basu S, Gil A. Does consumption of two portions of salmon per week enhance the antioxidant defense system in pregnant women? Antioxid Redox Signal. 2012 Jun 15;16(12):1401-6. doi: 10.1089/ars.2012.4508. Epub 2012 Feb 21.

  PMID: 22229304 BACKGROUND

• Garcia-Rodriguez CE, Olza J, Aguilera CM, Mesa MD, Miles EA, Noakes PS, Vlachava M, Kremmyda LS, Diaper ND, Godfrey KM, Calder PC, Gil A. Plasma inflammatory and vascular homeostasis biomarkers increase during human pregnancy but are not affected by oily fish intake. J Nutr. 2012 Jul;142(7):1191-6. doi: 10.3945/jn.112.158139. Epub 2012 May 23.

  PMID: 22623389 BACKGROUND

• Urwin HJ, Miles EA, Noakes PS, Kremmyda LS, Vlachava M, Diaper ND, Perez-Cano FJ, Godfrey KM, Calder PC, Yaqoob P. Salmon consumption during pregnancy alters fatty acid composition and secretory IgA concentration in human breast milk. J Nutr. 2012 Aug;142(8):1603-10. doi: 10.3945/jn.112.160804. Epub 2012 Jun 27.

  PMID: 22739373 BACKGROUND

• Urwin HJ, Miles EA, Noakes PS, Kremmyda LS, Vlachava M, Diaper ND, Godfrey KM, Calder PC, Vulevic J, Yaqoob P. Effect of salmon consumption during pregnancy on maternal and infant faecal microbiota, secretory IgA and calprotectin. Br J Nutr. 2014 Mar 14;111(5):773-84. doi: 10.1017/S0007114513003097. Epub 2013 Oct 16.

  PMID: 24128654 BACKGROUND

• Rossary A, Farges MC, Lamas B, Miles EA, Noakes PS, Kremmyda LS, Vlachava M, Diaper ND, Robinson SM, Godfrey KM, Calder PC, Vasson MP. Increased consumption of salmon during pregnancy partly prevents the decline of some plasma essential amino acid concentrations in pregnant women. Clin Nutr. 2014 Apr;33(2):267-73. doi: 10.1016/j.clnu.2013.04.013. Epub 2013 May 1.

  PMID: 23684555 BACKGROUND

MeSH Terms

Conditions

Dermatitis; Hypersensitivity; Asthma

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Philip C Calder, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2008-12

Locations

GB (1)