Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03344783
Other study ID # Weijia,Wu
Secondary ID
Status Completed
Phase N/A
First received November 7, 2017
Last updated November 13, 2017
Start date March 15, 2017
Est. completion date October 10, 2017

Study information

Verified date November 2017
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date October 10, 2017
Est. primary completion date June 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Weijia, Wu Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03721263 - Study of ASLAN004 in Healthy Subjects Phase 1
Completed NCT03922087 - No-worry Baby Project
Recruiting NCT04189978 - Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.
Completed NCT05442658 - Importance and Association of Gut Microbiota and Biochemical Metabolites on Children Allergic Disorder