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Completed

NCT Number: NCT03344783

The Effects of Early Life PUFA and R-TFA on AD: 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.

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Key information

Conditions

Allergic Disorder Hypersensitivity Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Weijia, Wu

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PUFA and R-TFA

Other

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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