Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study

Completed

• Conditions: Folic Acid Deficiency

• Registration Number: NCT04096521
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2018-08-02
• Primary Completion: 2018-11-20
• Study Completion: 2019-03-16
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-29
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum folic acid status	December 2018 - March 2019	The measurement of serum folic acid status is using LC-MS/MS
Genotyping MTHFR 677C-->T	December 2018 - March 2019	The assessment of MTHFR 677C--\>T using Real Time PCR
DNA methylation of IGF2 gene	December 2018 - March 2019	DNA methylation of IGF2 gene using pyrosequencing method

Secondary Outcome Measures

Name	Time	Method
Serum Adiponectin	December 2018-March 2019	The measurement of serum adiponection using electrochemiluminescence
Blood pressure	December 2018-March 2019	The blood pressure measurement using semi automatic device (Omron HBP1300)
Serum Homocysteine	December 2018-March 2019	The measurement of serum homocysteine using Electrochemiluminescen

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta, DKI Jakarta, Indonesia