Folic Acid DeficiencyNCT04096521
Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study
An observational study of Folic Acid Deficiency, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 3 to 40 years
- Conditions the study is for
- Folic Acid Deficiency
- How many people
- 254 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Aug 2018to 16 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- participant in the previous study
- apparently healthy
- data complete
- voluntarily to participate
Who cannot join
- not complete data
- migrate
- refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Folic Acid Deficiency
- Keywords
- serum folic acid, genotyping, dna methylation of IGF2, East Jakarta Cohort Study, mother-children
- Medical subject headings
- Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum folic acid status
The measurement of serum folic acid status is using LC-MS/MS
Measured: December 2018 - March 2019
Genotyping MTHFR 677C-->T
The assessment of MTHFR 677C-->T using Real Time PCR
Measured: December 2018 - March 2019
DNA methylation of IGF2 gene
DNA methylation of IGF2 gene using pyrosequencing method
Measured: December 2018 - March 2019
Secondary outcomes (3)
Serum Homocysteine
The measurement of serum homocysteine using Electrochemiluminescen
Measured: December 2018-March 2019
Serum Adiponectin
The measurement of serum adiponection using electrochemiluminescence
Measured: December 2018-March 2019
Blood pressure
The blood pressure measurement using semi automatic device (Omron HBP1300)
Measured: December 2018-March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start2 Aug 2018
- Primary completion20 Nov 2018
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folic Acid DeficiencyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Research and Higher Education of Republic Indonesia, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Lestari Octavia, Universitas Indonesia
- Investigators
- Rina RA Agustina, Doctoral, Study director, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096521
- Sponsor's protocol ID
- 0420/UN2.F1/ETIK/2018
- Status last verified
- Dec 2019
- First submitted
- 18 Sep 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will not share the IPD of the subject participated due to consent issue
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04096521
- Acronym / sponsor ID
- 0420/UN2.F1/ETIK/2018
- Conditions
- Folic Acid Deficiency
- Keywords
- serum folic acid, genotyping, dna methylation of IGF2, East Jakarta Cohort Study, mother-children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Ministry of Research and Higher Education of Republic Indonesia, United States Agency for International Development (USAID)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- participant in the previous study
- apparently healthy
- data complete
- voluntarily to participate
Key exclusion criteria (3 listed)
- not complete data
- migrate
- refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum folic acid status
Time frame: December 2018 - March 2019
The measurement of serum folic acid status is using LC-MS/MS
Genotyping MTHFR 677C-->T
Time frame: December 2018 - March 2019
The assessment of MTHFR 677C-->T using Real Time PCR
DNA methylation of IGF2 gene
Time frame: December 2018 - March 2019
DNA methylation of IGF2 gene using pyrosequencing method
3 secondary outcomes
Serum Homocysteine
Time frame: December 2018-March 2019
Serum Adiponectin
Time frame: December 2018-March 2019
Blood pressure
Time frame: December 2018-March 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. I will not share the IPD of the subject participated due to consent issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina RA Agustina, Doctoral study director
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Folic Acid Deficiency, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum folic acid status (time frame: December 2018 - March 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.