NCT03344783

Brief Summary

The purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the AD risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 7, 2017

Last Update Submit

November 13, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Eczema were determined by using the validated International Study of Asthma and Allergic in Children (ISAAC) questionnaire or doctors' diagnosis.

    Parental reported questions adapted from the International Study on Asthma and Allergy in Childhood (ISAAC) provided information on eczema.Researchers combined questions into current eczema (no, yes).

    From date of inclusion of pregnant women cohort until the date of eczema' diagnosis in children,follow-up time up to 18 years

  • Wheeze were determined by using the validated International Study of Asthma and Allergic in Children (ISAAC) questionnaire or doctors' diagnosis.

    Parental reported questions adapted from the International Study on Asthma and Allergy in Childhood (ISAAC) provided information on wheeze.Researchers combined questions into current wheeze (no, yes).

    From date of inclusion of pregnant women cohort until the date of wheeze' diagnosis in children,follow-up time up to 18 years

  • Asthma were determined by using the validated International Study of Asthma and Allergic in Children (ISAAC) questionnaire or doctors' diagnosis.

    Parental reported questions adapted from the International Study on Asthma and Allergy in Childhood (ISAAC) provided information on asthma.Researchers combined questions into current asthma (no, yes).

    From date of inclusion of pregnant women cohort until the date of asthma' diagnosis in children,follow-up time up to 18 years

  • Allergic rhinitis were determined by using the validated International Study of Asthma and Allergic in Children (ISAAC) questionnaire or doctors' diagnosis.

    Parental reported questions adapted from the International Study on Asthma and Allergy in Childhood (ISAAC) provided information on allergic rhinitis.Researchers combined questions into current allergic rhinitis (no, yes).

    From date of inclusion of pregnant women cohort until the date of allergic rhinitis' diagnosis in children,follow-up time up to 18 years

  • Sensitization were determined by IgE test.

    A child was considered sensitized if the IgE level for at least one of the seven allergens was ≥0.35 kUA/l, and nonsensitized if IgE level for all seven allergens was \<0.35 kUA/l.

    From date of inclusion of pregnant women cohort until the date of sensitization' diagnosis in children,follow-up time up to 18 years

Study Arms (1)

mother-children pairs

Other: PUFA and R-TFA

Interventions

PUFA and R-TFA exposure were assessed mainly from maternal dietary, blood sample or breast milk. Exposure period was restricted to early life. Dietary PUFA and R-TFA were measured by food-frequency questionnaire (FFQ) or diet history questionnaire (DHQ). The profile of PUFA and R-TFA in the blood sample and breast milk were examined by using gas chromatography

mother-children pairs

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Among these studies, most of them were performed in Europe. The sample size ranged from 65 to 4,976, with a median sample size of 708. One study included only boys, while the others included both sexes. Mother's mean age ranged from 27.5 to 38.7 years.

You may qualify if:

  • Studies needed to provide endpoints of AD, and risk estimates \[odds risk (OR), relative risk (RR) or hazard ratio (HR)\] for PUFA or R-TFA as the exposure. We included English language articles only, while scanned titles /abstracts of non-English language articles to evaluate agreement with the results published in English.

You may not qualify if:

  • Studies were excluded if they didn't report the profile of PUFA or R-TFA, or if they targeted participants with medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weijia, Wu

Guangzhou, Guangdong, China

Location

Related Publications (3)

  • Best KP, Gold M, Kennedy D, Martin J, Makrides M. Omega-3 long-chain PUFA intake during pregnancy and allergic disease outcomes in the offspring: a systematic review and meta-analysis of observational studies and randomized controlled trials. Am J Clin Nutr. 2016 Jan;103(1):128-43. doi: 10.3945/ajcn.115.111104. Epub 2015 Dec 16.

    PMID: 26675770BACKGROUND
  • Anandan C, Nurmatov U, Sheikh A. Omega 3 and 6 oils for primary prevention of allergic disease: systematic review and meta-analysis. Allergy. 2009 Jun;64(6):840-8. doi: 10.1111/j.1398-9995.2009.02042.x. Epub 2009 Apr 7.

    PMID: 19392990BACKGROUND
  • Wu WF, Wan KS, Wang SJ, Yang W, Liu WL. Prevalence, severity, and time trends of allergic conditions in 6-to-7-year-old schoolchildren in Taipei. J Investig Allergol Clin Immunol. 2011;21(7):556-62.

    PMID: 22312941BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Interventions

Fatty Acids, Unsaturated

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty AcidsLipids

Study Officials

  • Li Cai, PhD

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 17, 2017

Study Start

March 15, 2017

Primary Completion

June 20, 2017

Study Completion

October 10, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations