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

The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01936194

Enrollment

Registered

2013-09-05

Start date

2013-09-30

Completion date

2014-11-30

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

DIETARY_SUPPLEMENTDHA+EPA

DIETARY_SUPPLEMENTHigh Olive Oil

DIETARY_SUPPLEMENTDHA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026