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

NCT ID: NCT01936194

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Docosahexaenoic Acid (DHA)

infants receiving capsule containing DHA.

Group Type EXPERIMENTAL

DHA

Intervention Type DIETARY_SUPPLEMENT

High Olive Oil

infants receiving capsule without DHA and EPA.

Group Type OTHER

High Olive Oil

Intervention Type DIETARY_SUPPLEMENT

DHA+EPA

infants receiving capsule containing DHA and EPA.

Group Type EXPERIMENTAL

DHA+EPA

Intervention Type DIETARY_SUPPLEMENT

Interventions

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DHA+EPA

Intervention Type DIETARY_SUPPLEMENT

High Olive Oil

Intervention Type DIETARY_SUPPLEMENT

DHA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhiwei Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

International Peace Maternity and Child Health Hospital of China Welfare Institution

Huiyong Yin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Sciences

Bryan Liu, Ph.D.

Role: STUDY_DIRECTOR

Mead Johnson & Company

Locations

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International Peace Maternity and Child Health Hospital of China welfare Institute

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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6018

Identifier Type: -

Identifier Source: org_study_id

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