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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT04096521
Collaborator
Ministry of Research and Higher Education of Republic Indonesia (Other), United States Agency for International Development (USAID) (U.S. Fed)
254
1
7.4
34.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    254 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Aug 2, 2018
    Actual Primary Completion Date :
    Nov 20, 2018
    Actual Study Completion Date :
    Mar 16, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Serum folic acid status [December 2018 - March 2019]

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

    2. Genotyping MTHFR 677C-->T [December 2018 - March 2019]

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

    3. DNA methylation of IGF2 gene [December 2018 - March 2019]

      DNA methylation of IGF2 gene using pyrosequencing method

    Secondary Outcome Measures

    1. Serum Homocysteine [December 2018-March 2019]

      The measurement of serum homocysteine using Electrochemiluminescen

    2. Serum Adiponectin [December 2018-March 2019]

      The measurement of serum adiponection using electrochemiluminescence

    3. Blood pressure [December 2018-March 2019]

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

    Other Outcome Measures

    1. Nutritional status assessment [September 2018-December 2018]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitas Indonesia Jakarta DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Rina RA Agustina, Doctoral, Indonesia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Lestari Octavia, MSc, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT04096521
    Other Study ID Numbers:
    • 0420/UN2.F1/ETIK/2018
    First Posted:
    Sep 20, 2019
    Last Update Posted:
    Jan 2, 2020
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lestari Octavia, MSc, Indonesia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 2, 2020