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

NCT04096521 | Completed

• 1 other identifier: 0420/UN2.F1/ETIK/2018
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Folic Acid Deficiency

Keywords

serum folic acid; genotyping; dna methylation of IGF2; East Jakarta Cohort Study; mother-children

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Serum Homocysteine

  December 2018-March 2019

• Serum Adiponectin

  December 2018-March 2019

• Blood pressure

  December 2018-March 2019

Other Outcomes (1)

• Nutritional status assessment

  September 2018-December 2018

Study Arms (1)

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

Eligibility Criteria

• Age: 3 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead
• Ministry of Research and Higher Education of Republic Indonesia: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Universitas Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolated from the whole blood using standardized equipment and procedure of blood taking. DNA obtained from mother-children of the participant in the study

MeSH Terms

Conditions

Folic Acid Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rina RA Agustina, Doctoral

  Indonesia University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: August 2, 2018
• Primary Completion: November 20, 2018
• Study Completion: March 16, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)