The Role of Filaggrin and FADS Genes on the Concentrations of PUFA Towards Its Effect on Atopic Dermatitis in Infants (FLG-FADSgen)
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|ClinicalTrials.gov Identifier: NCT02401178|
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : May 17, 2018
|Condition or disease|
STUDY DESIGN Cross-sectional design is used to know the role of FADS1 and FADS2 gene polymorphism in LCPUFA composition at birth (from umbilical artery and buccal swab), Extended cross-sectional designed is used to look at FLG gene mutation effect as the predictor of the emergence of atopic dermatitis, FADS1 and FADS2 gene polymorphism role in atopic dermatitis occurences, the role of DHA intake and DHA to AA ratio in preventing atopic dermatitis occurences in the first year of life.
STUDY POPULATION Target population is healthy term newborns. Affordable population is healthy term newborns in Jakarta. Study samples are healthy term newborns in Jakarta born in Primary Health Care in Kemayoran District, Central Jakarta whose parents consent to take part in this study.
METHODS Briefly, filaggrin gene mutation and FADS1 and FADS2 polymorphism will be examined from umbilical blood and LCPUFA level will be measured from umbilical artery and buccal swab in 400 newborns. The Material Transfer Agreement (MTA) from Indonesian Health Research and Development Institution (Badan Penelitian dan Pengembangan Kesehatan Republik Indonesia/LITBANGKES) will be included. Genotyping will be done by using iPLEX Gold chemistry (Sequenom) and MALDI-TOF (matrix assisted laser desorption ionization-time of flight) as the methods to detect allele differences.
Every month, breastfeeding; each duration of breastfeeding; formula intake; how much and what kind of formula given, if any (regular formula, hypoallergenic formula); will be monitored. At the time complementary feeding to breast milk starts, dietary analysis by Food Frequency Questionnaire (FFQ), and monitoring of body weight, length, head circumference and skin condition will be done.
If parents complain about the presence of skin disorders or there is a suspicion of AD occurfence, investigator's team will ask and accompany parents and subject to Dermatologist. If subject can not come, a home visit will be done, and photograph will be taken. The dermatologist will later confirm the diagnosis through the photo. LCPUFA level measurement will be done once more through buccal swab at the time atopic dermatitis occurs or at the end of the monitoring for subjects who do not acquire AD.
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||The Role of Fillagrin Gene Mutations and FADS Genes Variation Through Its Effect on the Concentration of Polyunsaturated Fatty Acids Towards the Occurance of Atopic Dermatitis in Indonesian Infants|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||July 2016|
For cross-sectional study design:
The dependent variables are LCPUFA composition from buccal. The independent variables are 17 SNP from FADS genes.
For extended cross-sectional study design:
The dependent variable is atopic dermatitis, while independent variables are:
17 SNP; LCPUFA and FLG gene mutation
- Number of atopic dermatitis in patients with FLG gene mutation, FADS1 or FADS2 gene polymorphisms [ Time Frame: one year ]Incidence of atopic dermatitis
- Association of FLG gene and atopic dermatitis [ Time Frame: One year ]Odds ratio of FLG gene and atopic dermatitis
- Association of LCPUFA composition and atopic dermatitis: [ Time Frame: One year ]Odds ratio of LCPUFA composition and atopic dermatitis:
- Analysis of genetic variation association of FADS1 & FADS2 over the level of LCPUFA [ Time Frame: one year ]Regression coefficient and determinant coefficient to see the association between the genetic variation of FADS1 to FADS3 genes over the change of LCPUFA composition
- Influence of several risk factors with atopic dermatitis [ Time Frame: one year ]Survival analysis to see the influence of several risk factors with atopic dermatitis
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401178
|Puskesmas Kemayoran (Primary Health Care in Kemayoran District)|
|Jakarta Pusat, Jakarta, Indonesia, 10650|
|Principal Investigator:||Conny F Tanjung, MD||Indonesia University|