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NCT01365975 · ClinicalTrials.gov registry record
Follow-up Study of Late Effects of Periconceptional Folic Acid in Mothers and Offspring in the Community Intervention Program Population: The Chinese Children and Families Study
A clinical trial of Pediatric Leukemia and Other Pediatric Cancers, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 1,382
- Enrollment target
- 1
- Study location
NCT01365975 is a study of Pediatric Leukemia and Other Pediatric Cancers that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,382 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01365975, a study of Pediatric Leukemia and Other Pediatric Cancers, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 1,382 participants
- Enrollment target
- 1
- Study location
Study Summary
Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate levels during pregnancy, and/or certain variants in the gene that encodes methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of 5-methyltetrahydrofolate \[the primary methyl donor in most metabolic pathways involving methylation including DNA methylation\] from 5,10 methylenetetrahydrofolate may be associated with reduced risks of certain adverse events during the prenatal period, birth weight and certain serious diseases in offspring, while other studies have raised concerns about increased risks of specific serious disorders. Only one study has examined late health effects in mothers that might be associated with use of periconceptional folic acid supplements. We propose to study potential health benefits and adverse effects of periconceptional folic acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will evaluate whether periconceptional folic acid supplements reduced risk of external congenital birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or increased for other pediatric disorders linked with periconceptional folic acid supplements including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors, breast and colorectal cancers and precursor conditions, and other cancers. We will also conduct exploratory assessment of other serious diseases in mothers. To increase the limited data on the morbidity and survival of children born with a major birth defect, particularly in low- or middle-income countries, we plan to assess morbidity and mortality outcomes in children identified with neural tube defects as part of our follow-up. The women and children who partici
Conditions Studied
Study Locations (1)
Maryland
- National Cancer Institute (NCI), 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,382 participants |
| Start Date | 2011-06-01 |
| Est. Completion | 2020-03-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365975
The ClinicalTrials.gov registry entry for NCT01365975 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pediatric Leukemia appearing as the primary indexed condition, and to 0 interventions.
NCT01365975 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01365975 about?
NCT01365975 is a clinical study titled "Follow-up Study of Late Effects of Periconceptional Folic Acid in Mothers and Offspring in the Community Intervention Program Population: The Chinese Children and Families Study". Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate levels during pregnancy, and/or certain variants in the gene that encodes methylenetetrahydrofolate reductase (MTHFR), a...
What is the current status of trial NCT01365975?
This trial is currently completed. The enrollment target is 1,382 participants. The study started on 2011-06-01. Estimated completion is 2020-03-02.
What conditions does trial NCT01365975 study?
This clinical trial studies the following conditions: Pediatric Leukemia, Other Pediatric Cancers.
Who is sponsoring clinical trial NCT01365975?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01365975 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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