Clinical trial NCT04096521: Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study
Official title: Serum Folic Acid Status, Genotyping MTHFR 677C-->T of the Mother and Serum Folic Acid Status, DNA Methylation of IGF2 Gene of the Children: East Jakarta Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Folic Acid Deficiency
Keywords: serum folic acid
genotyping
dna methylation of IGF2
East Jakarta Cohort Study
mother-children
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Ministry of Research and Higher Education of Republic Indonesia
name: United States Agency for International Development (USAID)
First posted: 2019-09-20
Enrollment: 254
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In 2014, the pregnant mothers in 10 public health centre and one sub-district hospital in East Jakarta were recruited in the study. They were in the third trimester gestation period, receive iron-folic acid supplementation and ANC. In 2018, the repeated collection was conducted to collect follow-up data. We also include peer of the subjects that lived in the same neighbourhood since the first cohort study and have children in the same age with cohort participant

Brief summary: This study is part of the East Jakarta Cohort Study to assess the current micronutrient status of the mothers and their children. The study also includes the assessment of genotyping of MTHFR 677C--\>T of the mother and DNA methylation of IGF2 gene of the children.

Detailed description: The initial study recruited 315 mothers in the public health centre and one district hospital in East Jakarta. The follow-up study is able to re-visit the 127 of them. This also includes 127 peers of the subject that lives in the same neighbourhood. The design of the study is case-cohort design, part study of the existing cohort. The assessment of the follow-up study includes the mother and the children born in the initial study. Anthropometric measurement, socioeconomic data from a structured questionnaire, biomarker assessment, blood pressure were obtained from the subjects.

Eligibility criteria: Inclusion Criteria:

* participant in the previous study
* apparently healthy
* data complete
* voluntarily to participate

Exclusion Criteria:

* not complete data
* migrate
* refuse to participate in the study

Primary outcomes:
measure: Serum folic acid status
timeFrame: December 2018 - March 2019
measure: Genotyping MTHFR 677C-->T
timeFrame: December 2018 - March 2019
measure: DNA methylation of IGF2 gene
timeFrame: December 2018 - March 2019
Secondary outcomes:
measure: Serum Homocysteine
timeFrame: December 2018-March 2019
measure: Serum Adiponectin
timeFrame: December 2018-March 2019
measure: Blood pressure
timeFrame: December 2018-March 2019
Other outcomes:
measure: Nutritional status assessment
timeFrame: September 2018-December 2018
Locations:
city: Jakarta
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Rina RA Agustina, Doctoral
role: STUDY_DIRECTOR
References: