Atopic Dermatitis Clinical Trial
— FLG-FADSgenOfficial 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
NCT number | NCT02401178 |
Other study ID # | IndonesiaU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | July 2016 |
Verified date | May 2018 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The incidence of atopic dermatitis has increased dramatically in this years. Atopic dermatitis occurs due to complex interactions between genetic and environmental factors. One of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene). Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which serves to form protein-lipid, thereby disrupting the skin permeability to water and outside particles such as allergens.8-14 Several attempts have been made to prevent the occurences and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life gives more consistent and protective results. In this study investigators would like to know about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from umbilical artery and buccal swab in early life and at the time AD occurs, to know about the diet at the time of AD occurrence, and to know the role of the ratio of DHA towards AA level in the development of AD due to their antagonistic effects, and to see the interactions between FLG gene, FADS gene and LCPUFA level in the development of AD.
Status | Completed |
Enrollment | 400 |
Est. completion date | July 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 12 Months |
Eligibility |
Inclusion Criteria: 1. Newborn: term, healthy, weighs more than 2500 gram, and has no congenital disorders 2. Mother : consents to take part in the study and signs the informed consent 3. Mother with normal gestational history without any complications such as gestational hypertension, gestational diabetes mellitus, not a vegetarian 4. Mother does not suffer severe illness during or after labor period 5. Mother does not get omega-3 and omega-6 supplementation during pregnancy and breastfeeding period Exclusion Criteria: 1. Mother : gets omega-3 or omega-6 supplementation 2. Newborn: gets omega-3 or omega-6 supplementation |
Country | Name | City | State |
---|---|---|---|
Indonesia | Puskesmas Kemayoran (Primary Health Care in Kemayoran District) | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Mead Johnson Nutrition |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of atopic dermatitis in patients with FLG gene mutation, FADS1 or FADS2 gene polymorphisms | Incidence of atopic dermatitis | one year | |
Secondary | Association of FLG gene and atopic dermatitis | Odds ratio of FLG gene and atopic dermatitis | One year | |
Secondary | Association of LCPUFA composition and atopic dermatitis: | Odds ratio of LCPUFA composition and atopic dermatitis: | One year | |
Secondary | Analysis of genetic variation association of FADS1 & FADS2 over the level of LCPUFA | Regression coefficient and determinant coefficient to see the association between the genetic variation of FADS1 to FADS3 genes over the change of LCPUFA composition | one year | |
Secondary | Influence of several risk factors with atopic dermatitis | Survival analysis to see the influence of several risk factors with atopic dermatitis | one year |
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