Atopic DermatitisFLG-FADSgenNCT02401178
The Role of Filaggrin and FADS Genes on the Concentrations of PUFA Towards Its Effect on Atopic Dermatitis in Infants
An observational study of Atopic Dermatitis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 1 hour to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 400 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2014to Jul 2016
- 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 1 hour to 12 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Newborn: term, healthy, weighs more than 2500 gram, and has no congenital disorders
- Mother : consents to take part in the study and signs the informed consent
- Mother with normal gestational history without any complications such as gestational hypertension, gestational diabetes mellitus, not a vegetarian
- Mother does not suffer severe illness during or after labor period
- Mother does not get omega-3 and omega-6 supplementation during pregnancy and breastfeeding period
Who cannot join
- Mother : gets omega-3 or omega-6 supplementation
- Newborn: gets omega-3 or omega-6 supplementation
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Puskesmas Kemayoran (Primary Health Care in Kemayoran District)
Jakarta Pusat, Jakarta Special Capital Region, 10650
About this study
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
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.
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Keywords
- FLG-FADS genes variations-LCPUFA-atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Well baby | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of atopic dermatitis in patients with FLG gene mutation, FADS1 or FADS2 gene polymorphisms
Incidence of atopic dermatitis
Measured: one year
Secondary outcomes (4)
Association of FLG gene and atopic dermatitis
Odds ratio of FLG gene and atopic dermatitis
Measured: One year
Association of LCPUFA composition and atopic dermatitis:
Odds ratio of LCPUFA composition and atopic dermatitis:
Measured: One year
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
Measured: one year
Influence of several risk factors with atopic dermatitis
Survival analysis to see the influence of several risk factors with atopic dermatitis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Principal investigator, M.F.Conny Tanjung, MD, Universitas Indonesia
- Investigators
- Conny F Tanjung, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401178
- Sponsor's protocol ID
- IndonesiaU
- Acronym
- FLG-FADSgen
- Status last verified
- May 2018
- First submitted
- 9 Dec 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tanjung C, Rzehak P, Sudoyo H, Mansyur M, Munasir Z, Immanuel S, Irawan R, Reischl E, Demmelmair H, Hadinegoro SR, Sjarif DR, Koletzko B. The association of fatty acid desaturase gene polymorphisms on long-chain polyunsaturated fatty acid composition in Indonesian infants. Am J Clin Nutr. 2018 Nov 1;108(5):1135-1144. doi: 10.1093/ajcn/nqy166.
PubMed 30475958
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02401178
- Acronym / sponsor ID
- FLG-FADSgen / IndonesiaU
- Conditions
- Atopic Dermatitis
- Keywords
- FLG-FADS genes variations-LCPUFA-atopic dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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 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.
Detailed description
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Well baby | – | –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 |
Who may qualify
- Ages
- 1 hour to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- Newborn: term, healthy, weighs more than 2500 gram, and has no congenital disorders
- Mother : consents to take part in the study and signs the informed consent
- Mother with normal gestational history without any complications such as gestational hypertension, gestational diabetes mellitus, not a vegetarian
- Mother does not suffer severe illness during or after labor period
- Mother does not get omega-3 and omega-6 supplementation during pregnancy and breastfeeding period
Key exclusion criteria (2 listed)
- Mother : gets omega-3 or omega-6 supplementation
- Newborn: gets omega-3 or omega-6 supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of atopic dermatitis in patients with FLG gene mutation, FADS1 or FADS2 gene polymorphisms
Time frame: one year
Incidence of atopic dermatitis
4 secondary outcomes
Association of FLG gene and atopic dermatitis
Time frame: One year
Association of LCPUFA composition and atopic dermatitis:
Time frame: One year
Analysis of genetic variation association of FADS1 & FADS2 over the level of LCPUFA
Time frame: one year
Influence of several risk factors with atopic dermatitis
Time frame: one year
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 May 2018.
- Derived from this study: PubMed 30475958Tanjung C, Rzehak P, Sudoyo H, Mansyur M, Munasir Z, Immanuel S, Irawan R, Reischl E, Demmelmair H, Hadinegoro SR, Sjarif DR, Koletzko B. The association of fatty acid desaturase gene polymorphisms on long-chain polyunsaturated fatty acid composition in Indonesian infants. Am J Clin Nutr. 2018 Nov 1;108(5):1135-1144. doi: 10.1093/ajcn/nqy166.
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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.
Conny F Tanjung, MD principal investigator
Universitas Indonesia
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 Atopic Dermatitis, run by Universitas Indonesia at 1 site in Indonesia.
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 5 inclusion and 2 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 May 2018. 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 Indonesia. 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?
Number of atopic dermatitis in patients with FLG gene mutation, FADS1 or FADS2 gene polymorphisms (time frame: one year). 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 NCT02401178, which also lists 1 linked publication.
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 May 2018.