The Effects of Early Life PUFA and R-TFA on AD: A Systematic Review and Meta-analysis

November 13, 2017 updated by: Li Cai, Sun Yat-sen University

The Effects of Early Life Polyunsaturated Fatty Acids and Ruminant Trans Fatty Acids on Allergic Diseases: A Systematic Review and Meta-analysis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of Allergic Diseases (AD) is rising dramatically worldwide especially in more industrialized countries during the past two decades, representing a substantial disease burden of individuals and health service cost. Early life nutritional exposures could modify the gene expression and susceptibility of allergic diseases (AD), yet the effects of early life polyunsaturated fatty acids (PUFA) and ruminant trans fatty acids (R-TFA) on AD remain unclear.Therefore,the investigators performed the meta-analysis and systematic review to evaluate whether early life natural exposure to PUFA and R-TFA affects the AD risk.

Study Type

Observational

Enrollment (Actual)

26

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
    • Guangdong
      • Guangzhou, Guangdong, China
        • Weijia, Wu

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mother-children pairs
Other: PUFA and R-TFA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema were determined by using the validated International Study of Asthma and Allergic in Children (ISAAC) questionnaire or doctors' diagnosis.
Time Frame: From date of inclusion of pregnant women cohort until the date of eczema' diagnosis in children,follow-up time up to 18 years
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.
Time Frame: From date of inclusion of pregnant women cohort until the date of wheeze' diagnosis in children,follow-up time up to 18 years
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.
Time Frame: From date of inclusion of pregnant women cohort until the date of asthma' diagnosis in children,follow-up time up to 18 years
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.
Time Frame: From date of inclusion of pregnant women cohort until the date of allergic rhinitis' diagnosis in children,follow-up time up to 18 years
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.
Time Frame: From date of inclusion of pregnant women cohort until the date of sensitization' diagnosis in children,follow-up time up to 18 years
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

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Li Cai, PhD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 15, 2017

Primary Completion (Actual)

June 20, 2017

Study Completion (Actual)

October 10, 2017

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Weijia,Wu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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