The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis

Not Applicable

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: DHA+EPA; Dietary Supplement: High Olive Oil; Dietary Supplement: DHA

• Registration Number: NCT01936194
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Woman is pregnant between 16 and 20 weeks
• Mother delivers after 36 weeks
• Mother is willing to breast-feed for four months
• Mother has potential to deliver a child with increased risk of atopic dermatitis
• Signed Informed Consent

Exclusion Criteria

• Mother is smoking
• Disease with influence on breast feeding
• Complicated pregnancy
• Allergic to seafood
• Allergic to soy
• Allergic to marine fish
• Mother has more than two salmon or tuna meals per week
• Mother is undergoing treatment with anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA+EPA	DHA+EPA	infants receiving capsule containing DHA and EPA.
High Olive Oil	High Olive Oil	infants receiving capsule without DHA and EPA.
Docosahexaenoic Acid (DHA)	DHA	infants receiving capsule containing DHA.

Primary Outcome Measures

Name	Time	Method
Metabolomics Study of PUFA	Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum
Lipid Analysis	Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum
Skin Prick Test to Common Allergens	4 months postpartum, 12 months postpartum
Clinical Assessment of IgE-mediated Allergic Eczema	4 months postpartum, 12 months postpartum

Secondary Outcome Measures

Name	Time	Method
Fatty Acid Desaturase (FADS) Genotypes	Baseline
immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies	Baseline
Medically-confirmed adverse events collected throughout the study period	12 months postpartum
Immunological Biomarkers	4 months postpartum, 12 months postpartum

Trial Locations

Locations (1)

International Peace Maternity and Child Health Hospital of China welfare Institute; 🇨🇳 Shanghai, Shanghai, China