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NCT Number: 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

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.

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Key information

Conditions

Folic Acid Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

3 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitas Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum folic acid status

    Time frame: December 2018 - March 2019

    The measurement of serum folic acid status is using LC-MS/MS

  2. Genotyping MTHFR 677C-->T

    Time frame: December 2018 - March 2019

    The assessment of MTHFR 677C-->T using Real Time PCR

  3. DNA methylation of IGF2 gene

    Time frame: December 2018 - March 2019

    DNA methylation of IGF2 gene using pyrosequencing method

Secondary outcomes

  1. Serum Homocysteine

    Time frame: December 2018-March 2019

    The measurement of serum homocysteine using Electrochemiluminescen

  2. Serum Adiponectin

    Time frame: December 2018-March 2019

    The measurement of serum adiponection using electrochemiluminescence

  3. Blood pressure

    Time frame: December 2018-March 2019

    The blood pressure measurement using semi automatic device (Omron HBP1300)

Other outcomes

  1. Nutritional status assessment

    Time frame: September 2018-December 2018

    Using antrhopometric measurement, using SECA for weight measurement, Shorrboard for height and standardized plastic tape for mid upper arm circumference.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 20, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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