Allergic DisorderNCT03344783
The Effects of Early Life PUFA and R-TFA on AD: A Systematic Review and Meta-analysis
An observational study of Allergic Disorder, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the AD risk. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergic Disorder
- What is being tested?
- PUFA and R-TFA
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 10 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Studies were excluded if they didn't report the profile of PUFA or R-TFA, or if they targeted participants with medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Disorder
- Being tested
- PUFA and R-TFA
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA and R-TFAOther
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
| Study group | Role | What they receive |
|---|---|---|
| mother-children pairs | Not described Receives: Other: PUFA and R-TFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From date of inclusion of pregnant women cohort until the date of sensitization' diagnosis in children,follow-up time up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Mar 2017
- Primary completion20 Jun 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allergic DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cai, Sun Yat-sen University
- Investigators
- Li Cai, PhD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344783
- Sponsor's protocol ID
- Weijia,Wu
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26675770Anandan 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.
PubMed 19392990Wu 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.
PubMed 22312941
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early Life Polyunsaturated Fatty Acids and Ruminant Trans Fatty Acids on Allergic Diseases: A Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT03344783
- Acronym / sponsor ID
- Weijia,Wu
- Conditions
- Allergic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the AD risk.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mother-children pairs | – | Other: PUFA and R-TFA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Studies were excluded if they didn't report the profile of PUFA or R-TFA, or if they targeted participants with medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUFA and R-TFAPUFA 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 | Other | mother-children pairs |
Primary outcome
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).
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).
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 26675770Best 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.
- Background: PubMed 19392990Anandan 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.
- Background: PubMed 22312941Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Cai, PhD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Disorder, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344783, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.