NCT01936194

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

August 27, 2013

Last Update Submit

September 15, 2016

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

  • 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

  • Clinical Assessment of IgE-mediated Allergic Eczema

    4 months postpartum, 12 months postpartum

Secondary Outcomes (4)

  • 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

Study Arms (3)

Docosahexaenoic Acid (DHA)

EXPERIMENTAL

infants receiving capsule containing DHA.

Dietary Supplement: DHA

High Olive Oil

OTHER

infants receiving capsule without DHA and EPA.

Dietary Supplement: High Olive Oil

DHA+EPA

EXPERIMENTAL

infants receiving capsule containing DHA and EPA.

Dietary Supplement: DHA+EPA

Interventions

DHA+EPADIETARY_SUPPLEMENT
DHA+EPA
High Olive OilDIETARY_SUPPLEMENT
High Olive Oil
DHADIETARY_SUPPLEMENT
Docosahexaenoic Acid (DHA)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Peace Maternity and Child Health Hospital of China welfare Institute

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Bryan Liu, Ph.D.

    Mead Johnson & Company

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 5, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CN(1)