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Clinical Trials in Taiwan / NCT07568561
Recruiting Observational

Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

NCT07568561 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Far Eastern Memorial Hospital
Phase
Observational
Started
2026-05-27
Last updated
2026-05-29

Condition(s) studied

Infant NeurodevelopmentNutritionMethylationBirth OutcomesPregnancyDietary QualityDietary Intake AssessmentHomocysteineTrimethylamine N-oxide (TMAO)

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Ｍaternal methyl-nutrient and other nutrition status — From enrollment to delivery (approximately 9 months)
    Maternal methyl-nutrient status will be assessed using the following measurements: * Blood biomarkers: plasma or serum concentrations of choline(µmol/L), betaine(µmol/L), RBC and serum folate(ng/mL), vitamin B12 (pg/mL) measured using by standard laboratory assays * Dietary intake: assessed using a validated Food Frequency Questionnaire (FFQ) and 3-day dietary records
  • Birth anthropometric measurements of the newborn — At birth
    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).
  • Infant neurodevelopmental outcomes — At 6, 12, and 24 months of age
    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

Trial sites (2)

FacilityCityRegionStatus
Far Eastern Memorial Hospital New Taipei City Taiwan Not Yet Recruiting
Far Eastern Memorial Hospital New Taipei City Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568561 on ClinicalTrials.gov ↗ ← All trials in Taiwan