- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07568561
Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
2026년 5월 27일 업데이트: Chi-Man Kuok, Far Eastern Memorial Hospital
Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms
This prospective cohort study examines the relationship between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment.
It integrates maternal dietary, biomarker, genetic, and microbiome data and follows children up to 24 months.
연구 개요
상세 설명
Evidence regarding the association between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment remains inconsistent.
To address this gap, the present study is designed to comprehensively evaluate maternal methyl-nutrient status-specifically dietary intake and concentrations of choline, folate, betaine, and vitamin B12-at different gestational stages, and to examine their associations with infant and early childhood neurodevelopmental outcomes.
This prospective mother-child cohort will recruit pregnant women aged 20-45 years from the Department of Obstetrics and Gynecology at Far Eastern Memorial Hospital who are receiving routine prenatal care and intend to deliver at the study site.
At each trimester, maternal dietary intake will be assessed using a semi-quantitative food frequency questionnaire and three-day dietary records, accompanied by the collection of blood and stool specimens.
These samples will be analyzed for metabolic biomarkers (e.g., homocysteine, trimethylamine N-oxide [TMAO], and gut microbiota composition).
Furthermore, genetic polymorphisms in one-carbon metabolism-related genes (e.g., MTHFR, PEMT), maternal DNA methylation status, and the expression of neurodevelopment-related genes will be measured to investigate potential mechanistic pathways.
Infant outcomes will include neonatal anthropometrics (gestational age, birth weight, length, and head circumference) and longitudinal neurodevelopmental assessments at 6 months, 12 months, and 24 months using the Bayley Scales of Infant and Toddler Development.
In addition, meconium and cord blood samples at birth and stool samples during infancy will be collected for analysis.
By integrating multi-dimensional data on maternal nutrition, genetics, metabolism, and the gut microbiome, this study seeks to construct a comprehensive model linking maternal methyl-nutrient status during pregnancy with offspring neurodevelopment.
The findings are expected to inform evidence-based recommendations for optimal methyl-nutrient intake during pregnancy in Taiwan, thereby contributing to prenatal nutrition guidelines and early preventive strategies against developmental delays.
연구 유형
관찰
등록 (추정된)
240
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: CHI MAN KUOK
- 전화번호: (+886) 952289592
- 이메일: carmentoe@hotmail.com
연구 장소
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New Taipei City, 대만
- 모병
- Far Eastern Memorial Hospital
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New Taipei City, 대만
- 아직 모집하지 않음
- Far Eastern Memorial Hospital
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연락하다:
- Far Eastern Memorial Hospital
- 전화번호: +886 2 8966 7000
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
120 pregnant women and their 120 newborns/infants
설명
Inclusion Criteria for Pregnant Women
- Aged 20-45 years
- Singleton pregnancy
- Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
Exclusion Criteria for Pregnant Women
- Diagnosed with major chronic diseases, including renal disease (defined as chronic kidney disease stage 3 or above or history of renal transplantation), liver disease (defined as liver cirrhosis or history of liver transplantation), or malignancy
- Alcohol consumption during pregnancy
- Diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status
Inclusion Criteria for Newborns
● Newborns delivered by mothers who participate in this study
Exclusion Criteria for Newborns
- Diagnosed with congenital anomalies, epilepsy, or severe brain injury
- Inability to complete neurodevelopmental assessments at 6 months, 1 year, and 2 years of age at the study site
- Infants whose mothers are diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maternal methyl-nutrient and other nutrition status
기간: From enrollment to delivery (approximately 9 months)
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Maternal methyl-nutrient status will be assessed using the following measurements:
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From enrollment to delivery (approximately 9 months)
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Birth anthropometric measurements of the newborn
기간: At birth
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This outcome will be assessed using medical records, including birth weight (grams), birth length (centimeters) , birth head circumference (centimeters), and gestational age at birth (weeks).
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At birth
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Infant neurodevelopmental outcomes
기간: At 6, 12, and 24 months of age
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Infant neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), including composite scores for cognitive, language, motor and social-emotional domains
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At 6, 12, and 24 months of age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plasma homocysteine concentration
기간: During pregnancy (each trimester) and at birth (cord blood)
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Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.
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During pregnancy (each trimester) and at birth (cord blood)
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Plasma trimethylamine N-oxide (TMAO) concentration
기간: During pregnancy (each trimester) and at birth (cord blood)
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Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.
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During pregnancy (each trimester) and at birth (cord blood)
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Global DNA methylation levels
기간: During pregnancy (each trimester) and at birth (cord blood)
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DNA methylation status (%) will be assessed using LINE-1 methylation analysis
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During pregnancy (each trimester) and at birth (cord blood)
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Gut microbiota composition
기간: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
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Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices
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During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
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Genetic polymorphisms related to methyl metabolism
기간: During pregnancy
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Genetic polymorphisms (e.g., MTHFR, PEMT) will be assessed using genotyping methods and reported as genotype frequencies (%)
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During pregnancy
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Expression levels of neurodevelopment-related genes
기간: During pregnancy (each trimester) and at birth (cord blood)
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Gene expression levels will be measured using RT-qPCR and report as relative expression levels
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During pregnancy (each trimester) and at birth (cord blood)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dietary intake and diet quality
기간: From enrollment through pregnancy to 4 months postpartum
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Dietary intake will be assessed using a Food Frequency Questionnaire (FFQ) and 3-day dietary records, including assessment of nutrient intake (grams/day ,mg/day)and dietary patterns.
Diet quality will be derived from these data
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From enrollment through pregnancy to 4 months postpartum
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 27일
기본 완료 (추정된)
2029년 1월 18일
연구 완료 (추정된)
2029년 1월 18일
연구 등록 날짜
최초 제출
2026년 4월 20일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 27일
마지막으로 확인됨
2026년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 114224-F
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
임신에 대한 임상 시험
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The Nazareth Hospital, Israel완전한Streptococcus B Carrier State Complicating Pregnancy이스라엘