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

Atopic Dermatitis Clinical Trial

Official title:

The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01936194
• Other study ID #: 6018
• Status: Withdrawn
• Phase: N/A
• First received: August 27, 2013
• Last updated: September 15, 2016
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: September 2016
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• DHA+EPA

• High Olive Oil

• DHA

Locations

Country	Name	City	State
China	International Peace Maternity and Child Health Hospital of China welfare Institute	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Chinese Academy of Sciences, International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid Analysis		Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum	No
Primary	Metabolomics Study of PUFA		Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum	No
Primary	Skin Prick Test to Common Allergens		4 months postpartum, 12 months postpartum	No
Primary	Clinical Assessment of IgE-mediated Allergic Eczema		4 months postpartum, 12 months postpartum	No
Secondary	Fatty Acid Desaturase (FADS) Genotypes		Baseline	No
Secondary	immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies		Baseline	No
Secondary	Immunological Biomarkers		4 months postpartum, 12 months postpartum	No
Secondary	Medically-confirmed adverse events collected throughout the study period		12 months postpartum	No