Back to resultsUnderstanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Primary Purpose
Pregnancy; Spina Bifida, Fetal, Environmental Exposure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Folic Acid Tablet
Sponsored by
About this trial
This is an interventional basic science trial for Pregnancy; Spina Bifida, Fetal focused on measuring Spina Bifida, Folic Acid, DNA Methylation, arsenic
Eligibility Criteria
Inclusion Criteria:
- Women (18+) with a prior pregnancy affected by spina bifida
- Available for required study visits
Exclusion Criteria:
- 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
Sites / Locations
- National Institute of Neurosciences and Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Folic Acid
Arm Description
5 mg folic acid supplement by mouth once a day for 12 weeks
Outcomes
Primary Outcome Measures
Changes in DNA Methylation patterns
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05500690
First Posted
August 10, 2022
Last Updated
August 11, 2022
Sponsor
Boston Children's Hospital
Collaborators
National Institute of Neurosciences and Hospital, Dhaka
1. Study Identification
Unique Protocol Identification Number
NCT05500690
Brief Title
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Official Title
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institute of Neurosciences and Hospital, Dhaka
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy; Spina Bifida, Fetal, Environmental Exposure
Keywords
Spina Bifida, Folic Acid, DNA Methylation, arsenic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Folic Acid
Arm Type
Experimental
Arm Description
5 mg folic acid supplement by mouth once a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid Tablet
Intervention Description
5 mg folic acid supplement
Primary Outcome Measure Information:
Title
Changes in DNA Methylation patterns
Description
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
Time Frame
Week 1 and Week 12
Secondary Outcome Measure Information:
Title
Changes in serum folate concentration
Description
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.
Time Frame
Week 1 and Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women (18+) with a prior pregnancy affected by spina bifida
Available for required study visits
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maitreyi Mazumdar, MD, MPH
Phone
617-355-2918
Email
maitreyi.mazumdarmdmph@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sudipta K Mukherjee, MBBS, MS
Phone
+880 171-170-9096
Email
sudipta70@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maitreyi Mazumdar, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sudipta K Mukherjee, MBBS, MS
Organizational Affiliation
National Institute of Neurosciences and Hospital, Dhaka
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Neurosciences and Hospital
City
Dhaka
ZIP/Postal Code
1207
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudipta K Mukherjee, MBBS, MS
Phone
+880 171-170-9096
Email
sudipta70@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hafiza S Suchanda, MPH
Phone
+880 178-390-5535
Email
ntd.coordinatorbd@gmail.com
First Name & Middle Initial & Last Name & Degree
Sudipta K Mukherjee, MBBS, MS
12. IPD Sharing Statement
Learn more about this trial
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
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