Trials Sponsors Conditions Drugs Pricing

Conditions

Pregnancy; Spina Bifida, Fetal Environmental Exposure

Keywords

Spina BifidaFolic AcidDNA Methylationarsenic

Outcome Measures

Primary Outcomes (1)

Changes in DNA Methylation patterns
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
Week 1 and Week 12

Secondary Outcomes (1)

Changes in serum folate concentration
Week 1 and Week 12

Study Arms (1)

Folic Acid

EXPERIMENTAL

5 mg folic acid supplement by mouth once a day for 12 weeks

Dietary Supplement: Folic Acid Tablet

Interventions

Folic Acid TabletDietary supplement

5 mg folic acid supplement

Folic Acid

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Women (18+) with a prior pregnancy affected by spina bifida
Available for required study visits

You may not qualify if:

Sponsors & Collaborators

National Institute of Neurosciences and Hospital, Dhaka
Governmentcollaborator
Boston Children's Hospital
Otherlead

Study Sites (1)

National Institute of Neurosciences and Hospital

Dhaka, 1207, Bangladesh

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Maitreyi Mazumdar, MD, MPH
Boston Children's Hospital
PRINCIPAL INVESTIGATOR
Sudipta K Mukherjee, MBBS, MS
National Institute of Neurosciences and Hospital, Dhaka
PRINCIPAL INVESTIGATOR

Enrollment

69 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Neurology

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 15, 2022

Study Start

October 15, 2023

Actual (reported)

Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Folic Acid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Folic Acid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations