Pregnancy; Spina Bifida, FetalNCT05500690
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
A study testing Folic Acid Tablet in people with Pregnancy; Spina Bifida, Fetal and Environmental Exposure, run by Boston Children's Hospital at 1 site in Bangladesh.
Trial summary
Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy; Spina Bifida, Fetal, Environmental Exposure
- What is being tested?
- Folic Acid Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Oct 2023to 1 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women (18+) with a prior pregnancy affected by spina bifida
- Available for required study visits
Who cannot join
- Personal history of diabetes or gestational diabetes
- Current anticonvulsant medication use
- History of pregnancy affected by identified genetic syndrome associated with neural tube defect such as Trisomy 18
- Current pregnancy
- Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
National Institute of Neurosciences and Hospital
Dhaka, 1207
About this study
Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure.
In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.
Read the detailed description
The investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. Folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. The investigators will compare DNA methylation in blood and folate levels before and after folic acid use.
- Being tested
- Folic Acid Tablet
- Keywords
- Spina Bifida, Folic Acid, DNA Methylation, arsenic
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid TabletDietary supplement
5 mg folic acid supplement
| Study group | Role | What they receive |
|---|---|---|
| Folic Acid | Experimental | 5 mg folic acid supplement by mouth once a day for 12 weeks Receives: Dietary Supplement: Folic Acid Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DNA Methylation patterns
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
Measured: Week 1 and Week 12
Secondary outcomes (1)
Changes in serum folate concentration
Chemiluminescent Microparticle Immunoassay will be used to measure folate concentration. The investigators will assess changes in serum folate concentration before and after folic acid use.
Measured: Week 1 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Oct 2023
- Primary completion4 Dec 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy; Spina Bifida, FetalStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurosciences and Hospital, Dhaka
- Responsible party
- Principal investigator, Maitreyi Mazumdar, Boston Children's Hospital
- Investigators
- Maitreyi Mazumdar, MD, MPH, Principal investigator, Boston Children's HospitalSudipta K Mukherjee, MBBS, MS, Principal investigator, National Institute of Neurosciences and Hospital, Dhaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500690
- Sponsor's protocol ID
- IRB-P00043006
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
- ClinicalTrials.gov ID
- NCT05500690
- Acronym / sponsor ID
- IRB-P00043006
- Keywords
- Spina Bifida, Folic Acid, DNA Methylation, arsenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurosciences and Hospital, Dhaka
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Aug 2022 (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.
Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure.
In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.
Detailed description
The investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. Folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. The investigators will compare DNA methylation in blood and folate levels before and after folic acid use.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Folic Acid | Experimental | Dietary Supplement: Folic Acid Tablet5 mg folic acid supplement by mouth once a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women (18+) with a prior pregnancy affected by spina bifida
- Available for required study visits
Key exclusion criteria (5 listed)
- Personal history of diabetes or gestational diabetes
- Current anticonvulsant medication use
- History of pregnancy affected by identified genetic syndrome associated with neural tube defect such as Trisomy 18
- Current pregnancy
- Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid Tablet5 mg folic acid supplement | Dietary supplement | Folic Acid |
Primary outcome
Changes in DNA Methylation patterns
Time frame: Week 1 and Week 12
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
1 secondary outcome
Changes in serum folate concentration
Time frame: Week 1 and Week 12
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 17 Mar 2026.
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.
Maitreyi Mazumdar, MD, MPH principal investigator
Boston Children's Hospital
Sudipta K Mukherjee, MBBS, MS principal investigator
National Institute of Neurosciences and Hospital, Dhaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid Tablet in people with Pregnancy; Spina Bifida, Fetal and Environmental Exposure, run by Boston Children's Hospital at 1 site in Bangladesh.
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 2 inclusion and 5 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 17 Mar 2026. 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 Bangladesh. 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?
Changes in DNA Methylation patterns (time frame: Week 1 and Week 12). 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 17 Mar 2026.