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

Folic Acid Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096521
• Other study ID #: 0420/UN2.F1/ETIK/2018
• Status: Completed
• Start date: August 2, 2018
• Est. completion date: March 16, 2019

Study information

• Verified date: December 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: March 16, 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Folic Acid Deficiency

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia	Jakarta	DKI Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
Indonesia University	Ministry of Research and Higher Education of Republic Indonesia, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Serum folic acid status	The measurement of serum folic acid status is using LC-MS/MS	December 2018 - March 2019
Primary	Genotyping MTHFR 677C-->T	The assessment of MTHFR 677C-->T using Real Time PCR	December 2018 - March 2019
Primary	DNA methylation of IGF2 gene	DNA methylation of IGF2 gene using pyrosequencing method	December 2018 - March 2019
Secondary	Serum Homocysteine	The measurement of serum homocysteine using Electrochemiluminescen	December 2018-March 2019
Secondary	Serum Adiponectin	The measurement of serum adiponection using electrochemiluminescence	December 2018-March 2019
Secondary	Blood pressure	The blood pressure measurement using semi automatic device (Omron HBP1300)	December 2018-March 2019

External 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.