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

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

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.

Study Overview

• Status: Completed
• Conditions: Folic Acid Deficiency

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 Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

East Jakarta Cohort Study; One group included in the study was originated from mothers who participated in the first data collection pregnancy. The follow-up study included mothers and their children born as the subject in the follow-up in the study. This study also includes 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status assessment	Using antrhopometric measurement, using SECA for weight measurement, Shorrboard for height and standardized plastic tape for mid upper arm circumference.	September 2018-December 2018

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: United States Agency for International Development (USAID); Ministry of Research and Higher Education of Republic Indonesia
• Investigators: Study Director: Rina RA Agustina, Doctoral, Indonesia University

Publications and helpful links

Helpful Links

• The effect of folic acid supplementation on fetus growth and development
• The maternal folic acid supplementation results strengthen the link between folic acid supplementation during later pregnancy and epigenetic changes and identify a novel mechanism for regulation of ZFP57.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): March 16, 2019

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: genotyping; serum folic acid; dna methylation of IGF2; East Jakarta Cohort Study; mother-children
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Folic Acid Deficiency
• Other Study ID Numbers: 0420/UN2.F1/ETIK/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I will not share the IPD of the subject participated due to consent issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No