Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096521
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Ministry of Research and Higher Education of Republic Indonesia
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Lestari Octavia, Indonesia University

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
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.

Layout table for study information
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 : August 2, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : March 16, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096521


Locations
Layout table for location information
Indonesia
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
Layout table for investigator information
Study Director: Rina RA Agustina, Doctoral Indonesia University
Additional Information:
Layout table for additonal information
Responsible Party: Lestari Octavia, MSc, Indonesia University
ClinicalTrials.gov Identifier: NCT04096521    
Other Study ID Numbers: 0420/UN2.F1/ETIK/2018
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I will not share the IPD of the subject participated due to consent issue

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lestari Octavia, Indonesia University:
serum folic acid
genotyping
dna methylation of IGF2
East Jakarta Cohort Study
mother-children
Additional relevant MeSH terms:
Layout table for MeSH terms
Folic Acid Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders