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

September 15, 2016 updated by: Mead Johnson Nutrition

The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • International Peace Maternity and Child Health Hospital of China welfare Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Docosahexaenoic Acid (DHA)
infants receiving capsule containing DHA.
Dietary supplement: DHA
OTHER: High Olive Oil
infants receiving capsule without DHA and EPA.
Dietary supplement: High Olive Oil
EXPERIMENTAL: DHA+EPA
infants receiving capsule containing DHA and EPA.
Dietary supplement: DHA+EPA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

Chinese Academy of Sciences
International Peace Maternity and Child Health Hospital

Investigators

  • Principal Investigator: Zhiwei Liu, M.D., International Peace Maternity and Child Health Hospital of China Welfare Institution
  • Principal Investigator: Huiyong Yin, Ph.D., Chinese Academy of Sciences
  • Study Director: Bryan Liu, Ph.D., Mead Johnson & Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (ESTIMATE)

September 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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